SIGNATURE

GUDID 00889095276947

SIGNATURE TLIF TPS Spacer, Large, 8mm

GLOBUS MEDICAL, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00889095276947
• NIH Device Record Key: c8af126c-88f1-44dc-b6cf-e7e1a8c19c8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGNATURE
• Version Model Number: 368.308CS
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095276947 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143578

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-16
• Device Publish Date: 2020-03-08

On-Brand Devices [SIGNATURE]

• 00849044090895: SIGNATURE TLIF Spacer, R Large, 17mm
• 00849044090888: SIGNATURE TLIF Spacer, R Large, 16mm
• 00849044090871: SIGNATURE TLIF Spacer, R Large, 15mm
• 00849044090864: SIGNATURE TLIF Spacer, R Large, 14mm
• 00849044090857: SIGNATURE TLIF Spacer, R Large, 13mm
• 00849044090840: SIGNATURE TLIF Spacer, R Large, 12mm
• 00849044090833: SIGNATURE TLIF Spacer, R Large, 11mm
• 00849044090826: SIGNATURE TLIF Spacer, R Large, 10mm
• 00849044090819: SIGNATURE TLIF Spacer, R Large, 9mm
• 00849044090802: SIGNATURE TLIF Spacer, R Large, 8mm
• 00849044090796: SIGNATURE TLIF Spacer, R Large, 7mm
• 00849044090789: SIGNATURE TLIF Spacer, R Small, 17mm
• 00849044090772: SIGNATURE TLIF Spacer, R Small, 16mm
• 00849044090765: SIGNATURE TLIF Spacer, R Small, 15mm
• 00849044090758: SIGNATURE TLIF Spacer, R Small, 14mm
• 00849044090741: SIGNATURE TLIF Spacer, R Small, 13mm
• 00849044090734: SIGNATURE TLIF Spacer, R Small, 12mm
• 00849044090727: SIGNATURE TLIF Spacer, R Small, 11mm
• 00849044090710: SIGNATURE TLIF Spacer, R Small, 10mm
• 00849044090703: SIGNATURE TLIF Spacer, R Small, 9mm
• 00849044090697: SIGNATURE TLIF Spacer, R Small, 8mm
• 00849044090680: SIGNATURE TLIF Spacer, R Small, 7mm
• 00849044073485: SIGNATURE TLIF Spacer, MIS, Large, 17mm
• 00849044073478: SIGNATURE TLIF Spacer, MIS, Large, 15mm
• 00849044073461: SIGNATURE TLIF Spacer, MIS, Large, 13mm
• 00849044073454: SIGNATURE TLIF Spacer, MIS, Large, 12mm
• 00849044073447: SIGNATURE TLIF Spacer, MIS, Large, 11mm
• 00849044073430: SIGNATURE TLIF Spacer, MIS, Large, 10mm
• 00849044073423: SIGNATURE TLIF Spacer, MIS, Large, 9mm
• 00849044073416: SIGNATURE TLIF Spacer, MIS, Large, 8mm
• 00849044073409: SIGNATURE TLIF Spacer, MIS, Large, 7mm
• 00849044073393: SIGNATURE TLIF Spacer, Large, 17mm
• 00849044073386: SIGNATURE TLIF Spacer, Large, 15mm
• 00849044073379: SIGNATURE TLIF Spacer, Large, 13mm
• 00849044073362: SIGNATURE TLIF Spacer, Large, 12mm
• 00849044073355: SIGNATURE TLIF Spacer, Large, 11mm
• 00849044073348: SIGNATURE TLIF Spacer, Large, 10mm
• 00849044073331: SIGNATURE TLIF Spacer, Large, 9mm
• 00849044073324: SIGNATURE TLIF Spacer, Large, 8mm
• 00849044073317: SIGNATURE TLIF Spacer, Large, 7mm
• 00849044073300: SIGNATURE TLIF Spacer, MIS, Small, 17mm
• 00849044073294: SIGNATURE TLIF Spacer, MIS, Small, 15mm
• 00849044073287: SIGNATURE TLIF Spacer, MIS, Small, 13mm
• 00849044073270: SIGNATURE TLIF Spacer, MIS, Small, 12mm
• 00849044073263: SIGNATURE TLIF Spacer, MIS, Small, 11mm
• 00849044073256: SIGNATURE TLIF Spacer, MIS, Small, 10mm
• 00849044073249: SIGNATURE TLIF Spacer, MIS, Small, 9mm
• 00849044073232: SIGNATURE TLIF Spacer, MIS, Small, 8mm
• 00849044073225: SIGNATURE TLIF Spacer, MIS, Small, 7mm
• 00849044073218: SIGNATURE TLIF Spacer, Small, 17mm