Identity
- Trade Name
- Baby Gorilla/Gorilla Plating System FDA UDI
- Generic Name
- Orthopaedic fixation implant alignment tool FDA UDI
- Device Name
- Precision Guide Set Screw FDA UDI
- Model / Reference
- P51-980-5003 FDA UDI
- Description
- Precision Guide Set Screw FDA UDI
Identifiers
- Catalog Number
- P51-980-5003 FDA UDI
- Primary DI / UDI-DI
- 00889795050823 FDA UDI
- 510(k) Number
- K190365 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation implant alignment tool 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Orthopaedic fixation implant alignment tool
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 Orthopaedic fixation implant alignment tool.
- Flux-C Cervical Interbody — ULRICH MEDICAL USA, INC. · Class II
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- U1™ Hip — UNITED ORTHOPEDIC CORP. · Class I
- U2™ Knee — UNITED ORTHOPEDIC CORP. · Class I
- U-Motion II — UNITED ORTHOPEDIC CORP. · Class I
- Flux-C Cervical Interbody — ULRICH MEDICAL USA, INC. · Class II
- Easyspine — Ldr Spine USA · Class I
Cleared under the same submission
K190365 also covers:
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/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 23b8b994-00ae-4a16-9643-b4e865bca1e2 35 fields · synced May 30, 2026