Identity
- Trade Name
- Gorilla Plating System FDA UDI
- Generic Name
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- 30 mm Dogbone Plate w/ Compression FDA UDI
- Model / Reference
- P53-151-0005 FDA UDI
- Description
- 30 mm Dogbone Plate w/ Compression FDA UDI
Identifiers
- Catalog Number
- P53-151-0005 FDA UDI
- Primary DI / UDI-DI
- 00889795010247 FDA UDI
- 510(k) Number
- K140397 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
- Length — 30 Millimeter FDA UDI
Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Gorilla Plating System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile.
- ANTHEM — GLOBUS MEDICAL, INC. · Class II
- Proximal Humeral Locking Plate Ⅱ, Combi-holes — Double Medical Technology Inc. · Class II
- ANTHEM — GLOBUS MEDICAL, INC. · Class II
- ANTHEM — GLOBUS MEDICAL, INC. · Class II
- ANTHEM — GLOBUS MEDICAL, INC. · Class II
- ACUMED — ACUMED LLC · Class II
- ANTHEM — GLOBUS MEDICAL, INC. · Class II
- V-TEK™ — Zimmer, Inc. · Class II
Cleared under the same submission
K140397 also covers:
- Gorilla Plating System — Paragon 28
- Gorilla Plating System — Paragon 28
- Gorilla Plating System — Paragon 28
- Gorilla Plating System — Paragon 28
- Gorilla Plating System — Paragon 28
- Gorilla Plating System — Paragon 28
- Gorilla Plating System — Paragon 28
- Gorilla Plating System — Paragon 28
- Gorilla Plating System — Paragon 28
- Gorilla Plating System — Paragon 28
- Gorilla Plating System — Paragon 28
- Gorilla Plating System — Paragon 28
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA UDI 672ff07b-ef44-41db-a11b-443d74f3d4f5 36 fields · synced May 31, 2026