Identity
- Trade Name
- ACE-FISCHER®DISTRACTION WIRE FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Model / Reference
- 1046-91-001 FDA UDI
Identifiers
- Catalog Number
- 104691001 FDA UDI
- Primary DI / UDI-DI
- 00887868010774 FDA UDI
- FDA Product Code
- HXK FDA UDIHTY FDA UDI
- GMDN Term
- External orthopaedic fixation system, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI888.3040 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
Ace-Fischer®distraction Wire by Biomet Orthopedics, Inc. — Class I — 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
K801594 also covers:
- ACE FISCHER™FOOT FRAME ELEVATOR — Biomet Orthopedics, Inc.
- ACE-FISCHER ™FOOT FRAME CROSS BAR — Biomet Orthopedics, Inc.
- ACE-FISCHER ™FOOT FRAME POSTERIOR ANGLE — Biomet Orthopedics, Inc.
- ACE-FISCHER ™LARGE FOOT FRAME — Biomet Orthopedics, Inc.
- ACE-FISCHER ™MEDIUM FOOT FRAME — Biomet Orthopedics, Inc.
- ACE-FISCHER ™MEDIUM FOOT RING — Biomet Orthopedics, Inc.
- ACE-FISCHER ™UNIVERSAL JOINT — Biomet Orthopedics, Inc.
- ACE-FISCHER®OLIVE WIRE — Biomet Orthopedics, Inc.
- ACE-FISCHER®PIN HOLDER BOLT — Biomet Orthopedics, Inc.
- ADAPTOR ROD — Biomet Orthopedics, Inc.
- ADAPTOR ROD — Biomet Orthopedics, Inc.
- CONNECTING ROD — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 95c4bc9d-f214-42b9-b97e-d15b7193f462 36 fields · synced May 30, 2026