Identity
- Trade Name
- DFS DISTAL RADIUS FIXATOR FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Model / Reference
- 04170 FDA UDI
Identifiers
- Catalog Number
- 04170 FDA UDI
- Primary DI / UDI-DI
- 00887868082375 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- External orthopaedic fixation system, single-use 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: External orthopaedic fixation system, single-use
Dfs Distal Radius Fixator by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External orthopaedic fixation system, single-use.
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- ARBOR — GLOBUS MEDICAL, INC. · Class II
- DRACO — HNM TOTAL RECON LLC · Class II
- PREFIX FIXATOR — Orthofix, Inc. · Class II
- RINGFIX — Stryker Corp. · Class II
Cleared under the same submission
K951357 also covers:
- DFS DIMENSION DISTAL RADIUS FIXATOR — Biomet Orthopedics, Inc.
- DFS DIMENSION DISTAL RADIUS FIXATOR — Biomet Orthopedics, Inc.
- DFS DISTAL RADIUS FIXATOR — Biomet Orthopedics, Inc.
- DFS DISTAL RADIUS FIXATOR — Biomet Orthopedics, Inc.
- DFS DISTAL RADIUS FIXATOR — Biomet Orthopedics, Inc.
- DFS DISTAL RADIUS FIXATOR — Biomet Orthopedics, Inc.
- DFS DISTAL RADIUS FIXATOR — Biomet Orthopedics, Inc.
- DFS DISTAL RADIUS FIXATOR — Biomet Orthopedics, Inc.
- DFS MINI EXTERNAL FIXATION SYSTEM — Biomet Orthopedics, Inc.
- DFS MINI EXTERNAL FIXATION SYSTEM — Biomet Orthopedics, Inc.
- DFS MINI EXTERNAL FIXATION SYSTEM — Biomet Orthopedics, Inc.
- DFS MINI EXTERNAL FIXATION SYSTEM — Biomet Orthopedics, Inc.
K993649 also covers:
- DFS — Biomet Orthopedics, Inc.
- DFS — Biomet Orthopedics, Inc.
- DFS — Biomet Orthopedics, Inc.
- DFS DIMENSION DISTAL RADIUS FIXATOR — Biomet Orthopedics, Inc.
- DFS DISTAL RADIUS FIXATOR — Biomet Orthopedics, Inc.
- DFS DISTAL RADIUS FIXATOR — Biomet Orthopedics, Inc.
- DFS DISTAL RADIUS FIXATOR — Biomet Orthopedics, Inc.
- DFS® Dimension Distal Radius Fixator — Biomet Orthopedics, Inc.
- DFS® Distal Radius Fixator — Biomet Orthopedics, Inc.
- DFS® Distal Radius Fixator — Biomet Orthopedics, Inc.
- DFS® Distal Radius Fixator — Biomet Orthopedics, Inc.
- DFS® FIXATOR — 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 45256b2e-8ffe-4fe4-a091-1c9dbbd80135 35 fields · synced Jun 8, 2026