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K2M Ozark® Cervical Plate System - HSA Registration DE0508089

Access comprehensive regulatory information for K2M Ozark® Cervical Plate System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508089 and owned by K2M, Inc.. The device was registered on May 12, 2023.

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 C
DE0508089
K2M Ozark® Cervical Plate System
HSA Registration Number: DE0508089
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Product Description

OZARK Cervical Plate Systems is indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0508089
Registration Date
May 12, 2023
Retention Due Date
May 11, 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
Model Information
Model Name(s)
Self-Tapping, Variable Screw; Size Ø4.0x10 mm Self-Starting, Variable Screw; Size Ø4.0x10 mm Self-Tapping, Variable Screw; Size Ø4.0x12 mm Self-Starting, Variable Screw; Size Ø4.0x12 mm Self-Tapping, Variable Screw; Size Ø4.0x14 mm Self-Starting, Variable Screw; Size Ø4.0x14 mm Self-Tapping, Variable Screw; Size Ø4.0x16 mm Self-Starting, Variable Screw; Size Ø4.0x16 mm Self-Tapping, Variable Screw; Size Ø4.0x18 mm Self-Starting, Variable Screw; Size Ø4.0x18 mm Self-Tapping, Variable Screw; Size Ø4.0x20 mm Self-Starting, Variable Screw; Size Ø4.0x20 mm Self-Tapping, Variable Screw; Size Ø4.0x22 mm Self-Starting, Variable Screw; Size Ø4.0x22 mm Self-Tapping, Variable Screw; Size Ø4.5x12 mm Self-Starting, Variable Screw; Size Ø4.5x12 mm Self-Tapping, Variable Screw; Size Ø4.5x14 mm Self-Starting, Variable Screw; Size Ø4.5x14 mm Self-Tapping, Variable Screw; Size Ø4.5x16 mm Self-Starting, Variable Screw; Size Ø4.5x16 mm Self-Tapping, Variable Screw; Size Ø4.5x18 mm Self-Starting, Variable Screw; Size Ø4.5x18 mm Fixed Screw, Self-Tapping; Size Ø4.0x10 mm Fixed Screw, Self-Starting; Size Ø4.0x10 mm Fixed Screw, Self-Tapping; Size Ø4.0x12 mm Fixed Screw, Self-Starting; Size Ø4.0x12 mm Fixed Screw, Self-Tapping; Size Ø4.0x14 mm Fixed Screw, Self-Starting; Size Ø4.0x14 mm Fixed Screw, Self-Tapping; Size Ø4.0x16 mm Fixed Screw, Self-Starting; Size Ø4.0x16 mm Fixed Screw, Self-Tapping; Size Ø4.0x18 mm Fixed Screw, Self-Starting; Size Ø4.0x18 mm Fixed Screw, Self-Tapping; Size Ø4.0x20 mm Fixed Screw, Self-Starting; Size Ø4.0x20 mm Fixed Screw, Self-Tapping; Size Ø4.0x22 mm Fixed Screw, Self-Starting; Size Ø4.0x22 mm Fixed Screw, Self-Tapping; Size Ø4.5x12 mm Fixed Screw, Self-Starting; Size Ø4.5x12 mm Fixed Screw, Self-Tapping; Size Ø4.5x14 mm Fixed Screw, Self-Starting; Size Ø4.5x14 mm Fixed Screw, Self-Tapping; Size Ø4.5x16 mm Fixed Screw, Self-Starting; Size Ø4.5x16 mm Fixed Screw, Self-Tapping; Size Ø4.5x18 mm Fixed Screw, Self-Starting; Size Ø4.5x18 mm Plate, 1 Level; Size 16 mm Plate, 1 Level; Size 18 mm Plate, 1 Level; Size 20 mm Plate, 1 Level; Size 22 mm Plate, 1 Level; Size 24 mm Plate, 1 Level; Size 26 mm Plate, 1 Level; Size 28 mm Plate, 1 Level; Size 30 mm Plate, 1 Level; Size 32 mm Plate, 1 Level; Size 34 mm Plate, 1 Level; Size 36 mm Plate, 2 Level; Size 32 mm Plate, 2 Level; Size 34 mm Plate, 2 Level; Size 36 mm Plate, 2 Level; Size 38 mm Plate, 2 Level; Size 40 mm Plate, 2 Level; Size 42 mm Plate, 2 Level; Size 44 mm Plate, 2 Level; Size 46 mm Plate, 2 Level; Size 48 mm Plate, 2 Level; Size 50 mm Plate, 2 Level; Size 52 mm Plate, 2 Level; Size 54 mm Plate, 3 Level; Size 48 mm Plate, 3 Level; Size 51 mm Plate, 3 Level; Size 54 mm Plate, 3 Level; Size 57 mm Plate, 3 Level; Size 60 mm Plate, 3 Level; Size 63 mm Plate, 3 Level; Size 66 mm Plate, 3 Level; Size 69 mm Plate, 3 Level; Size 72 mm Plate, 3 Level; Size 75 mm Plate, 3 Level; Size 78 mm Plate, 4 Level; Size 101 mm Plate, 4 Level; Size 61 mm Plate, 4 Level; Size 65 mm Plate, 4 Level; Size 69 mm Plate, 4 Level; Size 73 mm Plate, 4 Level; Size 77 mm Plate, 4 Level; Size 81 mm Plate, 4 Level; Size 85 mm Plate, 4 Level; Size 89 mm Plate, 4 Level; Size 93 mm Plate, 4 Level; Size 97 mm Plate, 5 Level; Size 100 mm Plate, 5 Level; Size 105 mm Plate, 5 Level; Size 110 mm Plate, 5 Level; Size 95 mm Awl; Size Ø2.3x10 mm Awl; Size Ø2.3x12 mm Drill; Size Ø2.3x12 mm Drill; Size Ø2.3x14 mm Drill; Size Ø2.3x16 mm Drill; Size Ø2.3x18 mm Temporary Fixation Pin Fine Temporary Fixation Pin Coarse Plate, 1 Level; Size 16 mm Plate, 1 Level; Size 18 mm Plate, 1 Level; Size 20 mm Plate, 1 Level; Size 22 mm Plate, 1 Level; Size 24 mm Plate, 1 Level; Size 26 mm Plate, 1 Level; Size 28 mm Plate, 1 Level; Size 30 mm Plate, 1 Level; Size 32 mm Plate, 1 Level; Size 34 mm Plate, 1 Level; Size 36 mm Plate, 2 Level; Size 32 mm Plate, 2 Level; Size 34 mm Plate, 2 Level; Size 36 mm Plate, 2 Level; Size 38 mm Plate, 2 Level; Size 40 mm Plate, 2 Level; Size 42 mm Plate, 2 Level; Size 44 mm Plate, 2 Level; Size 46 mm Plate, 2 Level; Size 48 mm Plate, 2 Level; Size 50 mm Plate, 2 Level; Size 52 mm Plate, 2 Level; Size 54 mm Plate, 3 Level; Size 48 mm Plate, 3 Level; Size 51 mm Plate, 3 Level; Size 54 mm Plate, 3 Level; Size 57 mm Plate, 3 Level; Size 60 mm Plate, 3 Level; Size 63 mm Plate, 3 Level; Size 66 mm Plate, 3 Level; Size 69 mm Plate, 3 Level; Size 72 mm Plate, 3 Level; Size 75 mm Plate, 3 Level; Size 78 mm Plate, 4 Level; Size 101 mm Plate, 4 Level; Size 61 mm Plate, 4 Level; Size 65 mm Plate, 4 Level; Size 69 mm Plate, 4 Level; Size 73 mm Plate, 4 Level; Size 77 mm Plate, 4 Level; Size 81 mm Plate, 4 Level; Size 85 mm Plate, 4 Level; Size 89 mm Plate, 4 Level; Size 93 mm Plate, 4 Level; Size 97 mm Plate, 5 Level; Size 100 mm Plate, 5 Level; Size 105 mm Plate, 5 Level; Size 110 mm Plate, 5 Level; Size 95 mm
Model Identifier(s)
8801-04010CA 8801-04010DA 8801-04012CA 8801-04012DA 8801-04014CA 8801-04014DA 8801-04016CA 8801-04016DA 8801-04018CA 8801-04018DA 8801-04020CA 8801-04020DA 8801-04022CA 8801-04022DA 8801-04512CA 8801-04512DA 8801-04514CA 8801-04514DA 8801-04516CA 8801-04516DA 8801-04518CA 8801-04518DA 8801-14010CA 8801-14010DA 8801-14012CA 8801-14012DA 8801-14014CA 8801-14014DA 8801-14016CA 8801-14016DA 8801-14018CA 8801-14018DA 8801-14020CA 8801-14020DA 8801-14022CA 8801-14022DA 8801-14512CA 8801-14512DA 8801-14514CA 8801-14514DA 8801-14516CA 8801-14516DA 8801-14518CA 8801-14518DA 8801-41F16G 8801-41F18G 8801-41F20G 8801-41F22G 8801-41F24G 8801-41F26G 8801-41F28G 8801-41F30G 8801-41F32G 8801-41F34G 8801-41F36G 8801-42F32G 8801-42F34G 8801-42F36G 8801-42F38G 8801-42F40G 8801-42F42G 8801-42F44G 8801-42F46G 8801-42F48G 8801-42F50G 8801-42F52G 8801-42F54G 8801-43F48G 8801-43F51G 8801-43F54G 8801-43F57G 8801-43F60G 8801-43F63G 8801-43F66G 8801-43F69G 8801-43F72G 8801-43F75G 8801-43F78G 8801-44F101G 8801-44F61G 8801-44F65G 8801-44F69G 8801-44F73G 8801-44F77G 8801-44F81G 8801-44F85G 8801-44F89G 8801-44F93G 8801-44F97G 8801-45F100G 8801-45F105G 8801-45F110G 8801-45F95G 8801-90054 8801-90056 8801-90067 8801-90069 8801-90071 8801-90073 8801-90075 8801-90078 AA01-41F16V AA01-41F18V AA01-41F20V AA01-41F22V AA01-41F24V AA01-41F26V AA01-41F28V AA01-41F30V AA01-41F32V AA01-41F34V AA01-41F36V AA01-42F32V AA01-42F34V AA01-42F36V AA01-42F38V AA01-42F40V AA01-42F42V AA01-42F44V AA01-42F46V AA01-42F48V AA01-42F50V AA01-42F52V AA01-42F54V AA01-43F48V AA01-43F51V AA01-43F54V AA01-43F57V AA01-43F60V AA01-43F63V AA01-43F66V AA01-43F69V AA01-43F72V AA01-43F75V AA01-43F78V AA01-44F101V AA01-44F61V AA01-44F65V AA01-44F69V AA01-44F73V AA01-44F77V AA01-44F81V AA01-44F85V AA01-44F89V AA01-44F93V AA01-44F97V AA01-45F100V AA01-45F105V AA01-45F110V AA01-45F95V