Identity
- Trade Name
- Gorilla Plating System FDA UDI
- Generic Name
- Orthopaedic implantation sleeve, reusable FDA UDI
- Device Name
- Gorilla, Ankle Fx, Threaded Tower FDA UDI
- Model / Reference
- P51-900-2001 FDA UDI
- Description
- Gorilla, Ankle Fx, Threaded Tower FDA UDI
Identifiers
- Catalog Number
- P51-900-2001 FDA UDI
- Primary DI / UDI-DI
- 00889795018069 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic implantation sleeve, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Category: Orthopaedic implantation sleeve, reusable
Gorilla Plating System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implantation sleeve, reusable.
- Arthrex® — Arthrex, Inc. · Class I
- gSource — GSOURCE, LLC. · Class I
- FITBONE TAA SYSTEM — Orthofix, Inc. · Class II
- RIGID SUPRA ENTRY SLEEVE 13MM — Zimmer, Inc. · Class I
- Jet-X — Smith & Nephew, Inc. · Class II
- Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class I
- Salvo® Spine System — Spine Wave, Inc. · Class I
- DRILL SLEEVE — Biomet Orthopedics, Inc. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA UDI 0e649a41-85c3-4d29-9b9d-e376e3181c40 34 fields · synced Jun 8, 2026