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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
- Implantable bone washer FDA UDI
- Device Name
- GORILLA R3CON Washer, Flat/Dome Screw, Ø2.7, Ø3.5 & Ø4.2 STERILE FDA UDI
- Model / Reference
- P50-153-WS00-S FDA UDI
- Description
- GORILLA R3CON Washer, Flat/Dome Screw, Ø2.7, Ø3.5 & Ø4.2 STERILE FDA UDI
Identifiers
- Catalog Number
- P50-153-WS00-S FDA UDI
- Primary DI / UDI-DI
- 00889795031594 FDA UDI
- 510(k) Number
- K241262 FDA UDI
- FDA Product Code
- HTN FDA UDI
- GMDN Term
- Implantable bone washer 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Implantable bone washer
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 Implantable bone washer.
- ISOLA — Depuy Spine, Inc. · Class II
- Spiked Gridlock Screw Washer — Trilliant Surgical LLC · Class II
- ALPHALOK Plating System — Vilex, Inc. · Class II
- FLAT WASHER — Biomet Orthopedics, Inc. · Class II
- Fixcet Spinal Facet Screw System — Xtant Medical Holdings, Inc. · U
- LEOS Cannulated Screw System — Tyber Medical · Class II
- FacetLink System — WALDEMAR LINK GmbH & Co. KG · U
- Washers — Trimed, INC. · Class II
Cleared under the same submission
K241262 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
- Precision MIS Bunion 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 9cd9eabf-eaa6-45cc-9bc8-a35c7f7f8229 35 fields · synced Jun 8, 2026