Identity
- Trade Name
- OMNIMAX FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Model / Reference
- 99-5924 FDA UDI
Identifiers
- Catalog Number
- 99-5924 FDA UDI
- Primary DI / UDI-DI
- 00841036274696 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
MR Conditional FDA UDI
Category: Orthopaedic bone wire
Omnimax by Biomet Microfixation, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone wire.
- mahe medical GmbH — mahe medical gmbh · Class II
- SALVATION™ — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- SMOOTH K-WIRE, DOUBLE END TROCAR POINT — Biomet Orthopedics, Inc. · Class II
- mahe medical GmbH — mahe medical gmbh · Class II
- OIC Variable Angle Small Fragment Locking Plate System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- THP™ Hip Fracture Plating System — Biomet Orthopedics, 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
- .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.
- 3.0MMX250MM 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Microfixation, Inc
Sources (1)
- FDA UDI abf309bd-375a-4ba7-b1ac-47a9d4285933 35 fields · synced Jun 8, 2026