Identity
- Trade Name
- Gorilla Plating System FDA UDI
- Generic Name
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- 28 Plate, 25 mm, 2-Hole Locking FDA UDI
- Model / Reference
- P53-101-2013 FDA UDI
- Description
- 28 Plate, 25 mm, 2-Hole Locking FDA UDI
Identifiers
- Catalog Number
- P53-101-2013 FDA UDI
- Primary DI / UDI-DI
- 00889795000989 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 — 25 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 |
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Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA UDI 8a2736cf-e6b2-4e27-aeec-9b04006d7b2c 36 fields · synced May 30, 2026