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Globus Medical ELSA ATP Spacer System - HSA Registration DE0504821

Access comprehensive regulatory information for Globus Medical ELSA ATP Spacer 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 DE0504821 and owned by Globus Medical Inc.. The device was registered on August 14, 2020.

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
DE0504821
Globus Medical ELSA ATP Spacer System
HSA Registration Number: DE0504821
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Product Description

The ELSA® spacer is a stand-alone lateral lumbar interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or more contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ELSA® spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0504821
Registration Date
August 14, 2020
Change Notification Approval Date
March 05, 2025
Retention Due Date
August 13, 2025
Product Owner
Short Name
Globus Medical Inc.
Address
Valley Forge Business Center, 2560 General Armistead Avenue, Audubon, PA 19403, Pennsylvania, UNITED STATES
Registrant
Address
151 LORONG CHUAN, NEW TECH PARK, #04-03, SINGAPORE 556741
Importer
Address
151 LORONG CHUAN, NEW TECH PARK, #04-03, SINGAPORE 556741 30 KALLANG PLACE, #06-06, SINGAPORE 339159
Model Information
Model Name(s)
ELSA ATP Spacer 20 x 35mm, 7-14mm ELSA ATP Spacer 20 x 40mm, 7-14mm ELSA ATP Spacer 20 x 45mm, 7-14mm ELSA ATP Spacer 20 x 50mm, 7-14mm ELSA ATP Spacer 20 x 55mm, 7-14mm ELSA ATP Spacer 20 x 60mm, 7-14mm ELSA ATP Spacer 20 x 65mm, 7-14mm ELSA ATP Spacer 20 x 35mm, 8-l5mm, 6° ELSA ATP Spacer 20 x 40mm, 8-l5mm, 6° ELSA ATP Spacer 20 x 45mm, 8-l5mm, 6° ELSA ATP Spacer 20 x 50mm, 8-l5mm, 6° ELSA ATP Spacer 20 x 55mm, 8-l5mm, 6° ELSA ATP Spacer 20 x 60mm, 8-l5mm, 6° ELSA ATP Spacer 20 x 65mm, 8-l5mm, 6° ELSA ATP Spacer 20 x 35mm,10-17mm ELSA ATP Spacer 20 x 40mm,10-17mm ELSA ATP Spacer 20 x 4Smm,10-17mm ELSA ATP Spacer 20 x 50mm,10-17mm ELSA ATP Spacer 20 x 55mm,10-17mm ELSA ATP Spacer 20 x 60mm,10-17mm ELSA ATP Spacer 20 x 65mm,10-17mm ELSA ATP Spacer 20 x 35mm,10-17mm, 10° ELSA ATP Spacer 20 x 40mm,10-17mm, 10° ELSA ATP Spacer 20 x 45mm,10-17mm, 10° ELSA ATP Spacer 20 x 50mm,10-17mm, 10° ELSA ATP Spacer 20 x 55mm,10-17mm, 10° ELSA ATP Spacer 20 x 60mm,10-17mm, 10° ELSA ATP Spacer 20 x 65mm,10-17mm, 10° Graft Plunger, 25° Angled Inserter Wrench Funnel Shaft, 25° Inserter, Angled, Down Cobb Elevator, Angled, Down, 10mm Cobb Elevator, Angled, Up, 10mm Cobb Elevator, Angled, Down, 20mm Cobb Elevator, Angled, Up, 20mm Cobb Elevator, Angled, Down, 7°, 10mm Cobb Elevator, Angled, Up, 7°, 10mm Cobb Elevator, Angled, Down, 7°, 20mm Cobb Elevator, Angled, Up, 7°, 20mm Disc Rongeur, Angled, Down, 4mm Disc Rongeur, Angled, Down, 6mm Disc Rongeur, Angled, Down, 250 x 4mm Disc Rongeur, Angled, Down, 250 x 6mm Double Rasp, Angled, Down, 12 x 20mm Cup Curette, Angled, Down, 6.5 x 9.5mm, Straight Cup Curette, Angled, Up, 6.5 x9.5mm, Straight Cup Curette, Angled, Down, 6.5 x 9.5mm, 15° Cup Curette, Angled, Up, 6.5 x 9.5mm, 15° Double Ring Curette, Angled, Down, 10mm, Straight Ring Curette, Angled, Down, 10mm, 7° Ring Curette, Angled, Up, 10mm, 7° Trial, Angled, Down, 20mm Wide, 0°, 5mm Trial, Angled, Down, 20mm Wide, 0°, 7mm Trial, Angled, Down, 20mm Wide, 0°, 9mm Trial, Angled, Down, 20mm Wide, 0°, 11mm Trial, Angled, Down, 20mm Wide, 0°, 13mm Trial, Angled, Down, 20mm Wide, 0°, 15mm Trial, Angled, Down, 20mm Wide, 0°, 17mm Trial, Angled, Down, 20mm Wide, 6°, 5mm Trial, Angled, Down, 20mm Wide, 6°, 7mm Trial, Angled, Down, 20mm Wide, 6°, 9mm Trial, Angled, Down, 18mm Wide, 0°, 5mm Trial, Angled, Down, 18mm Wide, 0°, 7mm Trial, Angled, Down, 18mm Wide, 0°, 9mm Trial, Angled, Down, 18mm Wide, 0°, 11mm Trial, Angled, Down, 18mm Wide, 0°, 13mm Trial, Angled, Down, 18mm Wide, 0°, 15mm Trial, Angled, Down, 18mm Wide, 0°, 17mm Trial, Angled, Down, 18mm Wide, 6°, 5mm Trial, Angled, Down, 18mm Wide, 6°, 7mm Trial, Angled, Down, 18mm Wide, 6°, 9mm Trial, Angled, Down, 18mm Wide, 6°, 11mm Trial, Angled, Down, 18mm Wide, 6°, 13mm Trial, Angled, Down, 18mm Wide, 6°, 15mm Trial, Angled, Down, 18mm Wide, 6°, 17mm Trial, Angled, Down, 22mm Wide, 0°, 5mm Trial, Angled, Down, 22mm Wide, 0°, 7mm Trial, Angled, Down, 22mm Wide, 0°, 9mm Trial, Angled, Down, 22mm Wide, 0°, 11mm Trial, Angled, Down, 22mm Wide, 0°, 13mm Trial, Angled, Down, 22mm Wide, 0°, 15mm Trial, Angled, Down, 22mm Wide, 0°, 17mm Trial, Angled, Down, 22mm Wide, 6°, 5mm Trial, Angled, Down, 22mm Wide, 6°, 7mm Trial, Angled, Down, 22mm Wide, 6°, 9mm Trial, Angled, Down, 22mm Wide, 6°, 11mm Trial, Angled, Down, 22mm Wide, 6°, 13mm Trial, Angled, Down, 22mm Wide, 6°, 15mm Trial, Angled, Down, 22mm Wide, 6°, 17mm Trial, Angled, Down, 20mm Wide, 10°, 11mm Trial, Angled, Down, 20mm Wide, 10°, 13mm Trial, Angled, Down, 20mm Wide, 10°, 15mm Trial, Angled, Down, 20mm Wide, 10°, 17mm Inserter, Angled, Down, Expandable Angled Drive Shaft Counter Torque, M6Xl Inserter, Angled, Down Angled Drive Shaft, T-Handle ELSA-ATP Implant Module Anterolateral Disc Prep Instruments I Graphic Case Anterolateral Disc Prep Instruments II Graphic Case Anterolateral Trial Instruments Graphic Case ELSA-ATP Trial/Screw Prep Instruments Graphic Case Anterolateral Insertion Instruments Graphic Case
Model Identifier(s)
1154.0035 1154.004 1154.0045 1154.005 1154.0055 1154.006 1154.0065 1154.0135 1154.014 1154.0145 1154.015 1154.0155 1154.016 1154.0165 1154.0435 1154.044 1154.0445 1154.045 1154.0455 1154.046 1154.0465 1154.0535 1154.054 1154.0545 1154.055 1154.0555 1154.056 1154.0565 6154.0611 6154.0614 6154.066 6154.098 6154.111 6154.1111 6154.112 6154.1121 6154.113 6154.1131 6154.114 6154.1141 6154.124 6154.1241 6154.126 6154.1261 6154.1403 6154.1501 6154.1502 6154.152 6154.1521 6154.153 6154.1533 6154.1534 6154.2005 6154.2007 6154.2009 6154.2011 6154.2013 6154.2015 6154.2017 6154.2025 6154.2027 6154.2029 6154.2105 6154.2107 6154.2109 6154.2111 6154.2113 6154.2115 6154.2117 6154.2125 6154.2127 6154.2129 6154.2131 6154.2133 6154.2135 6154.2137 6154.2205 6154.2207 6154.2209 6154.2211 6154.2213 6154.2215 6154.2217 6154.2225 6154.2227 6154.2229 6154.2231 6154.2233 6154.2235 6154.2237 6154.2331 6154.2333 6154.2335 6154.2337 6154.3001 6154.3002 6154.3003 6154.3005 6154.3012 9154.0011 9154.0061 9154.0062 9154.0063 9154.0064 9154.0065