Identity
- Trade Name
- Gorilla Plating System FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- 2.7 x 12 mm Locking Plate Screw FDA UDI
- Model / Reference
- P50-053-2712 FDA UDI
- Description
- 2.7 x 12 mm Locking Plate Screw FDA UDI
Identifiers
- Catalog Number
- P50-053-2712 FDA UDI
- Primary DI / UDI-DI
- 00889795000040 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.7 Millimeter FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Gorilla Plating System is a non-sterile, threaded rod with a slotted head used for internal orthopaedic fracture fixation. It's made of implant-grade metal and is suitable for various applications, including bone plate fixation or soft tissue stabilization. The device must be sterilized prior to use.
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
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- SMOOTH PEG — Biomet Orthopedics, Inc. · Class II
- AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- QWIX — Newdeal Sas · Class II
- TMS SYSTEM — BIOMET MICROFIXATION, INC · Class II
- Flow-Screw™ — Flow-Fx, LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA UDI 729602f1-5abc-4380-9658-85806ad4ca5d 35 fields · synced Jul 19, 2026