INDEPENDENCE

GUDID 00849044006100

Bone Screw, Fixed Angle 5.5mm, 35mm

GLOBUS MEDICAL, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00849044006100
• NIH Device Record Key: 447c5bbc-d8f3-4413-a7b8-5a2f2a0f8599
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INDEPENDENCE
• Version Model Number: 176.135
• 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: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849044006100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082252

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[00849044006100]

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: 2015-11-06

On-Brand Devices [INDEPENDENCE]

• 00849044037791: INDEPENDENCE Spacer, Large, 15°, 21mm
• 00849044037784: INDEPENDENCE Spacer, Large, 15°, 19mm
• 00849044037777: INDEPENDENCE Spacer, Large, 15°, 17mm
• 00849044037760: INDEPENDENCE Spacer, Large, 15°, 15mm
• 00849044037753: INDEPENDENCE Spacer, Large, 15°, 13mm
• 00849044037746: INDEPENDENCE Spacer, Large, 8°, 21mm
• 00849044037739: INDEPENDENCE Spacer, Large, 8°, 19mm
• 00849044037722: INDEPENDENCE Spacer, Large, 8°, 17mm
• 00849044037715: INDEPENDENCE Spacer, Large, 8°, 15mm
• 00849044037708: INDEPENDENCE Spacer, Large, 8°, 13mm
• 00849044037692: INDEPENDENCE Spacer, Large, 8°, 11mm
• 00849044037685: INDEPENDENCE Spacer, Small, 15° 17mm
• 00849044037678: INDEPENDENCE Spacer, Small, 15°, 15mm
• 00849044037661: INDEPENDENCE Spacer, Small, 15°, 13mm
• 00849044037654: INDEPENDENCE Spacer, Small, 15°, 11mm
• 00849044037647: INDEPENDENCE Spacer, Small, 8°, 17mm
• 00849044037630: INDEPENDENCE Spacer, Small, 8°, 15mm
• 00849044037623: INDEPENDENCE Spacer, Small, 8°, 13mm
• 00849044037616: INDEPENDENCE Spacer, Small, 8°, 11mm
• 00849044008036: INDEPENDENCE Spacer, 29X34, 15°, 21mm
• 00849044008029: INDEPENDENCE Spacer, 29X34, 15°, 19mm
• 00849044008012: INDEPENDENCE Spacer, 29X34, 15°, 17mm
• 00849044008005: INDEPENDENCE Spacer, 29X34, 15°, 15mm
• 00849044007992: INDEPENDENCE Spacer, 29X34, 15°, 13mm
• 00849044007985: INDEPENDENCE Spacer, 29X34, 8°, 21mm
• 00849044007978: INDEPENDENCE Spacer, 29X34, 8°, 19mm
• 00849044007961: INDEPENDENCE Spacer, 29X34, 8°, 17mm
• 00849044007954: INDEPENDENCE Spacer, 29X34, 8°, 15mm
• 00849044007947: INDEPENDENCE Spacer, 29X34, 8°, 13mm
• 00849044007930: INDEPENDENCE Spacer, 29X34, 8°, 11mm
• 00849044007923: INDEPENDENCE Spacer, Medium, 15°, 21mm
• 00849044007916: INDEPENDENCE Spacer, Medium, 15°, 19mm
• 00849044007909: INDEPENDENCE Spacer, Medium, 15°, 17mm
• 00849044007893: INDEPENDENCE Spacer, Medium, 15°, 15mm
• 00849044007886: INDEPENDENCE Spacer, Medium, 15°, 13mm
• 00849044007879: INDEPENDENCE Spacer, Medium, 15°, 11mm
• 00849044007862: INDEPENDENCE Spacer, Medium, 8°, 21mm
• 00849044007855: INDEPENDENCE Spacer, Medium, 8°, 19mm
• 00849044007848: INDEPENDENCE Spacer, Medium, 8°, 17mm
• 00849044007831: INDEPENDENCE Spacer, Medium, 8°, 15mm
• 00849044007824: INDEPENDENCE Spacer, Medium, 8°, 13mm
• 00849044007817: INDEPENDENCE Spacer, Medium, 8°, 11mm
• 00849044006179: Bone Screw, Variable Angle 5.5mm, 40mm
• 00849044006162: Bone Screw, Variable Angle 5.5mm, 35mm
• 00849044006155: Bone Screw, Variable Angle 5.5mm, 30mm
• 00849044006148: Bone Screw, Variable Angle 5.5mm, 27.5mm
• 00849044006131: Bone Screw, Variable Angle 5.5mm, 25mm
• 00849044006124: Bone Screw, Variable Angle 5.5mm, 20mm
• 00849044006117: Bone Screw, Fixed Angle 5.5mm, 40mm
• 00849044006100: Bone Screw, Fixed Angle 5.5mm, 35mm