Identity
- Trade Name
- LCP FDA UDI
- Generic Name
- Orthopaedic implant aiming/guiding block attachment tool FDA UDI
- Device Name
- SAW GUIDE FOR 2.7MM LCP ULNA OSTEOTOMY PLATE FDA UDI
- Model / Reference
- 03.111.905 FDA UDI
- Description
- SAW GUIDE FOR 2.7MM LCP ULNA OSTEOTOMY PLATE FDA UDI
Identifiers
- Catalog Number
- 03111905 FDA UDI
- Primary DI / UDI-DI
- 10886982072634 FDA UDI
- 510(k) Number
- K113364 FDA UDI
- FDA Product Code
- HWC FDA UDIHRS FDA UDI
- GMDN Term
- Orthopaedic implant aiming/guiding block attachment tool FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 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
Category: Orthopaedic implant aiming/guiding block attachment tool
Lcp by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant aiming/guiding block attachment tool.
- Phantom Hindfoot TTC/TC Nail System — Paragon 28 · Class II
- OptimalMTP® — Forma Medical, Inc. · Class II
- EVOLUTION — MicroPort Orthopedics Inc. · Class I
- ALIF VERTIGRAFT — Depuy Spine, Inc. · Class I
- Baby Gorilla®/Gorilla® Plating System — Paragon 28 · Class I
- Tools - Screws — Trimed, INC. · Class I
- Tools - WFS (C) — Trimed, INC. · Class I
- Tools - WS3 — Trimed, INC. · Class I
Cleared under the same submission
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
- Synthes
Sources (1)
- FDA UDI 1841ea20-1402-4548-ab7c-e33edacf4795 36 fields · synced May 30, 2026