ELSA

GUDID 00889095257946

ELSA Spacer 20 x 50mm, 7-14mm

GLOBUS MEDICAL, INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 00889095257946
• NIH Device Record Key: cd45bf85-8a6d-4945-9d2a-19d9bc38b36b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELSA
• Version Model Number: 1122.0050
• Company DUNS: 139105691
• Company Name: GLOBUS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095257946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161379

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

[00889095257946]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-01
• Device Publish Date: 2021-01-24

On-Brand Devices [ELSA]

• 00889095334524: ELSA Spacer 20 x 65mm, 11-20mm, 15-30°
• 00889095334517: ELSA Spacer 20 x 60mm, 11-20mm, 15-30°
• 00889095334500: ELSA Spacer 20 x 55mm, 11-20mm, 15-30°
• 00889095334494: ELSA Spacer 20 x 50mm, 11-20mm, 15-30°
• 00889095334487: ELSA Spacer 20 x 45mm, 11-20mm, 15-30°
• 00889095334470: ELSA Spacer 20 x 40mm, 11-20mm, 15-30°
• 00889095334456: ELSA Spacer 20 x 65mm, 8-17mm, 5-20°
• 00889095334449: ELSA Spacer 20 x 60mm, 8-17mm, 5-20°
• 00889095334432: ELSA Spacer 20 x 55mm, 8-17mm, 5-20°
• 00889095334425: ELSA Spacer 20 x 50mm, 8-17mm, 5-20°
• 00889095334418: ELSA Spacer 20 x 45mm, 8-17mm, 5-20°
• 00889095334401: ELSA Spacer 20 x 40mm, 8-17mm, 5-20°
• 00889095258110: ELSA Spacer 20 x 65mm,10-17mm
• 00889095258103: ELSA Spacer 20 x 60mm,10-17mm
• 00889095258097: ELSA Spacer 20 x 55mm,10-17mm
• 00889095258080: ELSA Spacer 20 x 50mm,10-17mm
• 00889095258073: ELSA Spacer 20 x 45mm,10-17mm
• 00889095258066: ELSA Spacer 20 x 40mm,10-17mm
• 00889095258042: ELSA Spacer 20 x 65mm, 8-15mm, 6°
• 00889095258035: ELSA Spacer 20 x 60mm, 8-15mm, 6°
• 00889095258028: ELSA Spacer 20 x 55mm, 8-15mm, 6°
• 00889095258011: ELSA Spacer 20 x 50mm, 8-15mm, 6°
• 00889095258004: ELSA Spacer 20 x 45mm, 8-15mm, 6°
• 00889095257991: ELSA Spacer 20 x 40mm, 8-15mm, 6°
• 00889095257977: ELSA Spacer 20 x 65mm, 7-14mm
• 00889095257960: ELSA Spacer 20 x 60mm, 7-14mm
• 00889095257953: ELSA Spacer 20 x 55mm, 7-14mm
• 00889095257946: ELSA Spacer 20 x 50mm, 7-14mm
• 00889095257939: ELSA Spacer 20 x 45mm, 7-14mm
• 00889095257922: ELSA Spacer 20 x 40mm, 7-14mm
• 00193982313579: Single Anchor Inserter, Lateral