CALIBER

GUDID 00849044021417

CALIBER-L Spacer 18 x 55mm, 11-15mm, Leading Taper, Lordotic

GLOBUS MEDICAL, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00849044021417
• NIH Device Record Key: c98a2285-849f-4a4c-b452-1401ba518da2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CALIBER
• Version Model Number: 194.074
• 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

Customer Support Contacts

• Phone: +1(610)930-1800
• Email: info@globusmedical.com

Device Dimensions

• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849044021417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102293

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00849044021417]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-11-07

On-Brand Devices [CALIBER]

• 00849044022209: CALIBER-L Spacer 22 x 40mm, 7-10mm
• 00849044022193: CALIBER-L Spacer 22 x 45mm, 7-10mm
• 00849044022186: CALIBER-L Spacer 22 x 50mm, 7-10mm
• 00849044022179: CALIBER-L Spacer 22 x 55mm, 7-10mm
• 00849044022162: CALIBER-L Spacer 22 x 60mm, 7-10mm
• 00849044022155: CALIBER-L Spacer 22 x 40, 8-11mm, Lordotic
• 00849044022148: CALIBER-L Spacer 22 x 45, 8-11mm, Lordotic
• 00849044022131: CALIBER-L Spacer 22 x 50, 8-11mm, Lordotic
• 00849044022124: CALIBER-L Spacer 22 x 55, 8-11mm, Lordotic
• 00849044022117: CALIBER-L Spacer 22 x 60, 8-11mm, Lordotic
• 00849044022100: CALIBER-L Spacer 22 x 40mm, 10-13mm, Lordotic
• 00849044022094: CALIBER-L Spacer 22 x 45mm, 10-13mm, Lordotic
• 00849044022087: CALIBER-L Spacer 22 x 50mm, 10-13mm, Lordotic
• 00849044022070: CALIBER-L Spacer 22 x 55mm, 10-13mm, Lordotic
• 00849044022063: CALIBER-L Spacer 22 x 60mm, 10-13mm, Lordotic
• 00849044022056: CALIBER-L Spacer 16 x 40mm, 9-13mm
• 00849044022049: CALIBER-L Spacer 18 x 40, 8-11mm, Lordotic
• 00849044022032: CALIBER-L Spacer 18 x 45, 8-11mm, Lordotic
• 00849044022025: CALIBER-L Spacer 18 x 50, 8-11mm, Lordotic
• 00849044022018: CALIBER-L Spacer 18 x 55, 8-11mm, Lordotic
• 00849044022001: CALIBER-L Spacer 18 x 60, 8-11mm, Lordotic
• 00849044021998: CALIBER-L Spacer 18 x 50mm, 12-16mm, Trailing Taper
• 00849044021981: CALIBER-L Spacer 18 x 55mm, 12-16mm, Trailing Taper
• 00849044021974: CALIBER Spacer 18 x 60mm, 12-16mm, Trailing Taper
• 00849044021967: CALIBER-L Spacer 18 x 40mm, 12-16mm, Leading Taper
• 00849044021950: CALIBER-L Spacer 18 x 45mm, 12-16mm, Leading Taper
• 00849044021943: CALIBER-L Spacer 18 x 50mm, 12-16mm, Leading Taper
• 00849044021936: CALIBER-L Spacer 18 x 55mm, 12-16mm, Leading Taper
• 00849044021929: CALIBER-L Spacer 18 x 60mm, 12-16mm, Leading Taper
• 00849044021912: CALIBER-L Spacer 18 x 40mm, 7-10mm
• 00849044021905: CALIBER-L Spacer 18 x 45mm, 7-10mm
• 00849044021899: CALIBER-L Spacer 18 x 50mm, 7-10mm
• 00849044021882: CALIBER-L Spacer 18 x 55mm, 7-10mm
• 00849044021875: CALIBER-L Spacer 18 x 60mm, 7-10mm
• 00849044021868: CALIBER-L Spacer 16 x 25mm, 7-10mm
• 00849044021851: CALIBER-L Spacer 16 x 30mm, 7-10mm
• 00849044021844: CALIBER-L Spacer 16 x 35mm, 7-10mm
• 00849044021837: CALIBER-L Spacer 16 x 40mm, 7-10mm
• 00849044021820: CALIBER-L Spacer 16 x 25mm, 9-13mm
• 00849044021813: CALIBER-L Spacer 16 x 30mm, 9-13mm
• 00849044021806: CALIBER-L Spacer 16 x 35mm, 9-13mm
• 00849044021790: CALIBER-L Spacer 18 x 40mm, 8-11mm, Trailing Taper
• 00849044021783: CALIBER-L Spacer 18 x 45mm, 8-11mm, Trailing Taper
• 00849044021776: CALIBER-L Spacer 18 x 50mm, 8-11mm, Trailing Taper
• 00849044021769: CALIBER-L Spacer 18 x 55mm, 8-11mm, Trailing Taper
• 00849044021752: CALIBER-L Spacer 18 x 60mm, 8-11mm, Trailing Taper
• 00849044021745: CALIBER-L Spacer 18 x 40mm, 8-11mm, Leading Taper
• 00849044021738: CALIBER-L Spacer 18 x 45mm, 8-11mm, Leading Taper
• 00849044021721: CALIBER-L Spacer 18 x 50mm, 8-11mm, Leading Taper
• 00849044021714: CALIBER-L Spacer 18 x 55mm, 8-11mm, Leading Taper