Distal Fibula Plating System

GUDID B471126601050

Distal Fibula Plate Standard Syndesmosis Screw Holes, 5-Hole

GRAMERCY EXTREMITY ORTHOPEDICS LLC

Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: B471126601050
• NIH Device Record Key: b4fa5486-5673-4611-ac19-4cdaf5677a5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distal Fibula Plating System
• Version Model Number: 12660105
• Company DUNS: 080068420
• Company Name: GRAMERCY EXTREMITY ORTHOPEDICS LLC
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B471126601050 [Primary]

FDA Product Code

• HRS: Plate, fixation, bone

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: 2022-01-18
• Device Publish Date: 2022-01-10

On-Brand Devices [Distal Fibula Plating System]

• B471126601110: Distal Fibula Plate Standard Syndesmosis Screw Holes, 11-Hole
• B471126601090: Distal Fibula Plate Standard Syndesmosis Screw Holes, 9-Hole
• B471126601070: Distal Fibula Plate Standard Syndesmosis Screw Holes, 7-Hole
• B471126601050: Distal Fibula Plate Standard Syndesmosis Screw Holes, 5-Hole
• B471126600110: Distal Fibula Plate Deep Syndesmosis Fixation Holes, 11-Hole
• B471126600090: Distal Fibula Plate Deep Syndesmosis Fixation Holes, 9-Hole
• B471126600070: Distal Fibula Plate Deep Syndesmosis Fixation Holes, 7-Hole
• B471126600050: Distal Fibula Plate Deep Syndesmosis Fixation Holes, 5-Hole