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K2M Ravine™ Lateral Access System - HSA Registration DE0012427

Access comprehensive regulatory information for K2M Ravine™ Lateral Access System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0012427 and owned by K2M, Inc.. The device was registered on February 22, 2013.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0012427
K2M Ravine™ Lateral Access System
HSA Registration Number: DE0012427
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Product Description

The Ravine Lateral Retractor is an instrument used in conjunction with Aleutian Lateral IBF Devices. The Ravine Lateral Retractor has a dual flat blade platform for a true muscle splitting transpsoas approach that offers rigid fixation to the spine and an option for both a third and fourth blade.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0012427
Registration Date
February 22, 2013
Change Notification Approval Date
October 17, 2022
Retention Due Date
February 21, 2026
Product Owner
Short Name
K2M, Inc.
Address
600 Hope Parkway SE, Leesburg, Virginia, 20175, UNITED STATES
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model Information
Model Name(s)
RAVINE™ Lateral Access System Scalpel Blade Holder RAVINE™ Lateral Access System Rongeur, Size 3 mm RAVINE™ Lateral Access System Rongeur, Size 5 mm RAVINE™ Lateral Access System Straight Curette, Size #2 RAVINE™ Lateral Access System Straight Curette, Size #4 RAVINE™ Lateral Access System Angled Curette, Size #2 RAVINE™ Lateral Access System Angled Curette, Size #4 RAVINE™ Lateral Access System Curette, Size 11 mm RAVINE™ Lateral Access System Hess, Nerve Retractor, Size 90° 5 mm RAVINE™ Lateral Access System 12 FR Suction (Long) RAVINE™ Lateral Access System Reverse Angled Curette, Size #2 RAVINE™ Lateral Access System Reverse Angled Curette, Size #4 RAVINE™ Lateral Access System Cone Ring Curette, Size #3 RAVINE™ Lateral Access System End Plate Rasp, Size 12.7 mm RAVINE™ Lateral Access System Angled Cobb Elevator, Size 12.7 mm RAVINE™ Lateral Access System Flat Cobb Elevator, Size 19 mm RAVINE™ Lateral Access System Fixation Pin, Size 70 mm RAVINE™ Lateral Access System Fixation Pin, Size 80 mm RAVINE™ Lateral Access System Fixation Pin, Size 90 mm RAVINE™ Lateral Access System Fixation Pin, Size 100 mm RAVINE™ Lateral Access System Fixation Pin, Size 110 mm RAVINE™ Lateral Access System Fixation Pin, Size 120 mm RAVINE™ Lateral Access System Fixation Pin, Size 130 mm RAVINE™ Lateral Access System Fixation Pin, Size 140 mm RAVINE™ Lateral Access System Fixation Pin, Size 150 mm RAVINE™ Lateral Access System Fixation Pin, Size 160 mm RAVINE™ Lateral Access System Fixation Pin Driver, Size 15 RAVINE™ Lateral Access System Lateral Access Blade, Size 24x70 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 24x80 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 24x90 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 24x100 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 24x110 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 24x120 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 24x130 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 24x140 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 24x150 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 24x160 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size 13x70 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size 13x80 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size 13x90 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size 13x100 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size 13x110 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size 13x120 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size 13x130 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size 13x140 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size 13x150 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size 13x160 mm RAVINE™ Lateral Access System Fluoro Modulator RAVINE™ Lateral Access System Lateral Access Blade Shim RAVINE™ Lateral Access System Lateral Access Shim Inserter RAVINE™ Lateral Access System Lateral Access Shim Extractor RAVINE™ Lateral Access System Lateral Access Guide Wire, Size Ø3.0x330 mm RAVINE™ Lateral Access System Dissector, Size 6 mm RAVINE™ Lateral Access System Dissector, Size 14 mm RAVINE™ Lateral Access System Dissector, Size 24 mm RAVINE™ Lateral Access System Stabilization Arm Attachment RAVINE™ Lateral Access System Fluoro Saver Forceps RAVINE™ Lateral Access System Lateral Access Retractor RAVINE™ Lateral Access System Light Probe, Dual, Size 50 mm RAVINE™ Lateral Access System Light Source Adapter RAVINE™ Lateral Access System Light Source Adapter RAVINE™ Lateral Access System Light Source Adapter RAVINE™ Lateral Access System Light Source Adapter RAVINE™ Lateral Access System Forward Angled Curette, Size #2 RAVINE™ Lateral Access System Reverse Angled Curette, Size #2 RAVINE™ Lateral Access System Forward Angled Cobb, Size 12 mm RAVINE™ Lateral Access System Forward Angled Cobb, Size 19 mm RAVINE™ Lateral Access System Reversed Angled Cobb, Size 12 mm RAVINE™ Lateral Access System Reversed Angled Cobb, Size 19 mm RAVINE™ Lateral Access System Teardrop Curette, Size 11 mm RAVINE™ Lateral Access System Long Penfield 4 Bayoneted RAVINE™ Lateral Access System Angled Cobb Elevator, Size 19 mm RAVINE™ Lateral Access System Flat Cobb Elevator, Size 12.7 mm RAVINE™ Lateral Access System Angled Pituitary (Right), Size 3 mm RAVINE™ Lateral Access System Angled Pituitary (Right), Size 5 mm RAVINE™ Lateral Access System Angled Pituitary (Left), Size 3 mm RAVINE™ Lateral Access System Angled Pituitary (Left), Size 5 mm RAVINE™ Lateral Access System Fixation Pin, Size 170 mm RAVINE™ Lateral Access System Fixation Pin, Size 180 mm RAVINE™ Lateral Access System Fixation Pin, Size 190 mm RAVINE™ Lateral Access System Fixation Pin, Size 200 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 24x170 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 24x180 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 24x190 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 24x200 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size 13x170 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size 13x180 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size 13x190 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size 13x200 mm RAVINE™ Lateral Access System Fixation Pin, Size 210 mm RAVINE™ Lateral Access System 12 FR Suction Al Handle RAVINE™ Lateral Access System Lateral Access Blade, Size 18x70 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 18x80 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 18x90 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 18x100 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 18x110 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 18x120 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 18x130 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 18x140 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 18x150 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 18x160 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 18x170 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 18x180 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 18x190 mm RAVINE™ Lateral Access System Lateral Access Blade, Size 18x200 mm RAVINE™ Lateral Access System Dissector, Size 18 mm RAVINE™ Lateral Access System Dissector, Size 6 mm RAVINE™ Lateral Access System Dissector, Size 14mm RAVINE™ Lateral Access System Dissector, Size 18mm RAVINE™ Lateral Access System Dissector, Size 24mm RAVINE™ Lateral Access System Lateral Access Blade Spreader , Size (S) RAVINE™ Lateral Access System Lateral Access Blade Spreader , Size (M) RAVINE™ Lateral Access System Lateral Access Blade Spreader , Size (L) RAVINE™ Lateral Access System Lateral Access Blade Spreader , Size (XL) RAVINE™ Lateral Access System Lateral Access Blade Extender Offset Blade Offset Blade Offset Blade Offset Blade Offset Blade Offset Blade ACDF Pin ACDF Pin ACDF Pin ACDF Tapered Pin Cap RAVINE™ Lateral Access System Lateral Access Blade, Size24 x 70 mm RAVINE™ Lateral Access System Lateral Access Blade, Size24 x 80 mm RAVINE™ Lateral Access System Lateral Access Blade, Size24 x 90 mm RAVINE™ Lateral Access System Lateral Access Blade, Size24 x 100 mm RAVINE™ Lateral Access System Lateral Access Blade, Size24 x 110 mm RAVINE™ Lateral Access System Lateral Access Blade, Size24 x 120 mm RAVINE™ Lateral Access System Lateral Access Blade, Size24 x 130 mm RAVINE™ Lateral Access System Lateral Access Blade, Size24 x 140 mm RAVINE™ Lateral Access System Lateral Access Blade, Size24 x 150 mm RAVINE™ Lateral Access System Lateral Access Blade, Size24 x 160 mm RAVINE™ Lateral Access System Dissector, 24 mm RAVINE™ Lateral Access System Fixation Pin, Size70 mm RAVINE™ Lateral Access System Fixation Pin, Size80 mm RAVINE™ Lateral Access System Fixation Pin, Size90 mm RAVINE™ Lateral Access System Fixation Pin, Size100 mm RAVINE™ Lateral Access System Fixation Pin, Size110 mm RAVINE™ Lateral Access System Fixation Pin, Size120 mm RAVINE™ Lateral Access System Fixation Pin, Size130 mm RAVINE™ Lateral Access System Fixation Pin, Size140 mm RAVINE™ Lateral Access System Fixation Pin, Size150 mm RAVINE™ Lateral Access System Fixation Pin, Size160 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size13 x 70 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size13 x 80 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size13 x 90 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size13 x 100 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size13 x 110 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size13 x 120 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size13 x 130 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size13 x 140 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size13 x 150 mm RAVINE™ Lateral Access System A/P Lateral Access Blade, Size13 x 160 mm RAVINE™ Lateral Access System Lateral Access Guide Wire, SizeØ3 x 330 mm RAVINE™ Lateral Access System Lateral Access Blade, SizeShim RAVINE™ Lateral Access System Dissector, 6 mm RAVINE™ Lateral Access System Fixation Pin Driver, SizeSize 15 RAVINE™ Lateral Access System Fluoro Modulator RAVINE™ Lateral Access System Dissector, 14 mm RAVINE™ Lateral Access System Lateral Access Retractor RAVINE™ Lateral Access System Stabilization Arm, SizeAttachment RAVINE™ Lateral Access System Lateral Access Shim, SizeInserter RAVINE™ Lateral Access System Lateral Access Shim, SizeExtractor
Model Identifier(s)
2701-90000 2701-90001 2701-90002 2701-90003 2701-90004 2701-90005 2701-90006 2701-90007 2701-90010 2701-90011 2701-90012 2701-90013 2701-90014 2701-90015 2701-90016 2701-90017 2701-90028 2701-90029 2701-90030 2701-90031 2701-90032 2701-90033 2701-90034 2701-90035 2701-90036 2701-90037 2701-90038 2701-90039 2701-90040 2701-90041 2701-90042 2701-90043 2701-90044 2701-90045 2701-90046 2701-90047 2701-90048 2701-90049 2701-90050 2701-90051 2701-90052 2701-90053 2701-90054 2701-90055 2701-90056 2701-90057 2701-90058 2701-90059 2701-90060 2701-90061 2701-90062 2701-90063 2701-90064 2701-90065 2701-90066 2701-90067 2701-90068 2701-90069 2701-90072 2701-90073 2701-90074 2701-90075 2701-90076 2701-90077 2701-90078 2701-90079 2701-90080 2701-90081 2701-90082 2701-90083 2701-90084 2701-90085 2701-90086 2701-90089 2701-90091 2701-90092 2701-90094 2701-90095 2701-90096 2701-90097 2701-90098 2701-90099 2701-90100 2701-90101 2701-90102 2701-90103 2701-90104 2701-90105 2701-90106 2701-90110 2701-90133 2701-90134 2701-90135 2701-90136 2701-90137 2701-90138 2701-90139 2701-90140 2701-90141 2701-90142 2701-90143 2701-90144 2701-90145 2701-90146 2701-90147 2701-90148 2701-90149 2701-90150 2701-90151 2701-90152 2701-90154 2701-90155 2701-90156 2701-90157 2701-90158 2701-90215 2701-90216 2701-90217 2701-90223 2701-90224 2701-90225 2701-90240 2701-90242 2701-90244 2701-90266 K2-27-2001-01 K2-27-2001-02 K2-27-2001-03 K2-27-2001-04 K2-27-2001-05 K2-27-2001-06 K2-27-2001-07 K2-27-2001-08 K2-27-2001-09 K2-27-2001-10 K2-27-2002-01 K2-27-2003-01 K2-27-2003-02 K2-27-2003-03 K2-27-2003-04 K2-27-2003-05 K2-27-2003-06 K2-27-2003-07 K2-27-2003-08 K2-27-2003-09 K2-27-2003-10 K2-27-2005-01 K2-27-2005-02 K2-27-2005-03 K2-27-2005-04 K2-27-2005-05 K2-27-2005-06 K2-27-2005-07 K2-27-2005-08 K2-27-2005-09 K2-27-2005-10 K2-27-2006-01 K2-27-2012-01 K2-27-2013-01 K2-27-2014-01 K2-27-2019-01 K2-27-2024-01 K2-27-2025-01 K2-27-2041-01 K2-27-2042-01 K2-27-2043-01