Pure Global

Globus Medical ELSA Spacer System - HSA Registration DE0504820

Access comprehensive regulatory information for Globus Medical ELSA 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 DE0504820 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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS C
DE0504820
Globus Medical ELSA Spacer System
HSA Registration Number: DE0504820
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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
DE0504820
Registration Date
August 14, 2020
Change Notification Approval Date
February 13, 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, 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 Spacer 20 x 35mm, 7-14mm ELSA Spacer 20 x 40mm, 7-14mm ELSA Spacer 20 x 45mm, 7-14mm ELSA Spacer 20 x 50mm, 7-14mm ELSA Spacer 20 x 55mm, 7-14mm ELSA Spacer 20 x 60mm, 7-14mm ELSA Spacer 20 x 65mm, 7-14mm ELSA Spacer 20 x 35mm, 8-15mm, 6° ELSA Spacer 20 x 40mm, 8-15mm, 6° ELSA Spacer 20 x 45mm, 8-15mm, 6° ELSA Spacer 20 x 50mm, 8-15mm, 6° ELSA Spacer 20 x 55mm, 8-15mm, 6° ELSA Spacer 20 x 60mm, 8-15mm, 6° ELSA Spacer 20 x 65mm, 8-15mm, 6° ELSA Spacer 20 x 35mm,10-17mm ELSA Spacer 20 x 40mm,10-17mm ELSA Spacer 20 x 45mm,10-17mm ELSA Spacer 20 x 50mm,10-17mm ELSA Spacer 20 x 55mm,10-17mm ELSA Spacer 20 x 60mm,10-17mm ELSA Spacer 20 x 65mm,10-17mm ELSA Spacer 20 x 35mm,10-17mm, 10° ELSA Spacer 20 x 40mm,10-17mm, 10° ELSA Spacer 20 x 45mm,10-17mm, 10° ELSA Spacer 20 x 50mm,10-17mm, 10° ELSA Spacer 20 x 55mm,10-17mm, 10° ELSA Spacer 20 x 60mm,10-17mm, 10° ELSA Spacer 20 x 65mm,10-17mm, 10° ELSA Spacer 20 x 35mm, 8-17mm, 5-20° ELSA Spacer 20 x 40mm, 8-17mm, 5-20° ELSA Spacer 20 x 45mm, 8-17mm, 5-20° ELSA Spacer 20 x 50mm, 8-17mm, 5-20° ELSA Spacer 20 x 55mm, 8-17mm, 5-20° ELSA Spacer 20 x 60mm, 8-17mm, 5-20° ELSA Spacer 20 x 65mm, 8-17mm, 5-20° ELSA Spacer 20 x 35mm , 11-20mm, 15-30° ELSA Spacer 20 x 40mm, 11-20mm, 15-30° ELSA Spacer 20 x 45mm, 11-20mm, 15-30° ELSA Spacer 20 x 50mm, 11-20mm, 15-30° ELSA Spacer 20 x 55mm, 11-20mm, 15-30° ELSA Spacer 20 x 60mm, 11-20mm, 15-30° ELSA Spacer 20 x 65mm, 11-20mm, 15-30° Trial, 15°, 11mm 3.5mm Hex Driver Tip, 10° Adjustable Trial, 20mm, Parallel Adjustable Trial, 20mm Lordotic 3.5mm Angled Hex Driver, 10° Angled Holder Sleeve, 10° Angled Holder Shaft, 10° Angled Awl, 10° Sleeveless Awl, 10° 5.5mm Drill Tip, 10° 5.5mm Tap Tip, 10° ELSA Implant Graphic Case ELSA 5.5mm Bone Screw Module ELSA Parallel and 6° Implant Module ELSA 20° and 30° Implant Module
Model Identifier(s)
1122.0035 1122.004 1122.0045 1122.005 1122.0055 1122.006 1122.0065 1122.0135 1122.014 1122.0145 1122.015 1122.0155 1122.016 1122.0165 1122.0435 1122.044 1122.0445 1122.045 1122.0455 1122.046 1122.0465 1122.0535 1122.054 1122.0545 1122.055 1122.0555 1122.056 1122.0565 1122.1035 1122.104 1122.1045 1122.105 1122.1055 1122.106 1122.1065 1122.2035 1122.204 1122.2045 1122.205 1122.2055 1122.206 1122.2065 6122.0015 6122.0024 6122.02 6122.021 6122.0504 6122.0505 6122.0506 6122.0511 6122.0512 6122.0521 6122.0721 9122.0002 9122.0003 9122.0012 9122.0022