Identity
- Trade Name
- X FIX FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Model / Reference
- 09585 FDA UDI
Identifiers
- Catalog Number
- 09585 FDA UDI
- Primary DI / UDI-DI
- 00887868084430 FDA UDI
- 510(k) Number
- K981483 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: External orthopaedic fixation system, single-use
X Fix 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.
- TRUELOK EVO — Orthofix, Inc. · Class II
- Monkey Rings™ External Fixation System — Paragon 28 · Class II
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- TrueLok — Orthofix, Inc. · Class II
- 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
K981483 also covers:
- DFS SMALL FIXATOR — Biomet Orthopedics, Inc.
- DFS SMALL FIXATOR — Biomet Orthopedics, Inc.
- DFS SMALL FIXATOR — Biomet Orthopedics, Inc.
- DFS SMALL FIXATOR — Biomet Orthopedics, Inc.
- DFS SMALL FIXATOR — Biomet Orthopedics, Inc.
- OPTIROM ELBOW FIXATOR — Biomet Orthopedics, Inc.
- OPTIROM ELBOW FIXATOR — Biomet Orthopedics, Inc.
- OPTIROM ELBOW FIXATOR — Biomet Orthopedics, Inc.
- X FIX — 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 526fcb2c-536c-4e57-b446-c55c5ecf9eaf 35 fields · synced May 30, 2026