Identity
- Trade Name
- TRAUMA FIXATION SYSTEMS FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Model / Reference
- 03216 FDA UDI
Identifiers
- Catalog Number
- 03216 FDA UDI
- Primary DI / UDI-DI
- 00887868082108 FDA UDI
- 510(k) Number
- K831005 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Orthopaedic bone wire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
Category: Orthopaedic bone wire
Trauma Fixation Systems by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone wire.
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- mahe medical GmbH — mahe medical gmbh · Class II
- OIC Variable Angle Small Fragment Locking Plate System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- gSource — GSOURCE, LLC. · Class II
- APTUS — Medartis Inc. · Class II
- gSource — GSOURCE, LLC. · Class II
Cleared under the same submission
K831005 also covers:
- EXTERNAL DISTRACTION SYSTEM — BIOMET MICROFIXATION, INC
- EXTERNAL DISTRACTION SYSTEM — BIOMET MICROFIXATION, INC
- EXTERNAL DISTRACTION SYSTEM — BIOMET MICROFIXATION, INC
- EXTERNAL DISTRACTION SYSTEM — BIOMET MICROFIXATION, INC
- LIGATURE WIRE — BIOMET MICROFIXATION, INC
- LIGATURE WIRE — BIOMET MICROFIXATION, INC
- OMNIMAX — BIOMET MICROFIXATION, INC
- OMNIMAX — BIOMET MICROFIXATION, INC
- .062 X 8" GUIDE WIRE — Biomet Orthopedics, Inc.
- .062" DIA X 8" LONG — Biomet Orthopedics, Inc.
- 1.6MM X 150MM GUIDE WIRE — Biomet Orthopedics, Inc.
- 2.0MM X 250MM NON THD GUIDE WIRE — Biomet Orthopedics, Inc.
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
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 21d3a5f0-f850-4ed7-bef9-e693b6022d7b 36 fields · synced Jun 1, 2026