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Baby Gorilla®/Gorilla® Plating System
FDA UDIClass II (US FDA UDI)
by Paragon 28
Identity
- Trade Name
- Baby Gorilla®/Gorilla® Plating System FDA UDI
- Generic Name
- Osteotomy guide, reusable FDA UDI
- Device Name
- Preserve, SMO Allograft, Cutting Jig FDA UDI
- Model / Reference
- P01-954-0001 FDA UDI
- Description
- Preserve, SMO Allograft, Cutting Jig FDA UDI
Identifiers
- Catalog Number
- P01-954-0001 FDA UDI
- Primary DI / UDI-DI
- 00889795124340 FDA UDI
- 510(k) Number
- K203511 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Osteotomy guide, reusable 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Osteotomy guide, reusable
Baby Gorilla®/Gorilla® Plating System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Osteotomy guide, reusable.
- Legion — Smith & Nephew, Inc. · Class II
- MOBIO™ Total Knee System — b-ONE Ortho Corp. · Class II
- Persona® — Zimmer, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- Profix — Smith & Nephew, Inc. · Class II
- QUANTUM — IN2BONES · Class I
- Cut Guide — TREACE MEDICAL CONCEPTS, INC. · Class I
- UKNEE™ — UNITED ORTHOPEDIC CORP. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA UDI fd060df3-8a2d-49b6-8fa3-5065f1b9e2df 35 fields · synced May 29, 2026