Identity
- Trade Name
- BIOMET® 360 FDA UDI
- Generic Name
- Knee tibia prosthesis trial, reusable FDA UDI
- Model / Reference
- 32-360251 FDA UDI
Identifiers
- Catalog Number
- 32-360251 FDA UDI
- Primary DI / UDI-DI
- 00880304496019 FDA UDI
- 510(k) Number
- K093293 FDA UDI
- FDA Product Code
- JWH FDA UDIMBV FDA UDI
- GMDN Term
- Knee tibia prosthesis trial, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Knee tibia prosthesis trial, reusable
Biomet® 360 by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee tibia prosthesis trial, reusable.
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- INSTRUMENT — Howmedica Osteonics Corp. · Class II
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- U2™ Knee — UNITED ORTHOPEDIC CORP. · Class II
- ACS® — implantcast GmbH · Class I
- SIGMA — DEPUY ORTHOPAEDICS, INC. · Class I
- SIGMA — DEPUY ORTHOPAEDICS, INC. · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
Cleared under the same submission
K093293 also covers:
- BIOMET 360 — Biomet Orthopedics, Inc.
- BIOMET 360 KNEE SYSTEM — Biomet Orthopedics, Inc.
- BIOMET 360 KNEE SYSTEM — Biomet Orthopedics, Inc.
- BIOMET 360 KNEE SYSTEM — Biomet Orthopedics, Inc.
- BIOMET 360 KNEE SYSTEM — Biomet Orthopedics, Inc.
- BIOMET KNEE — Biomet Orthopedics, Inc.
- BIOMET® 360 — Biomet Orthopedics, Inc.
- BIOMET® 360 — Biomet Orthopedics, Inc.
- BIOMET® 360 — Biomet Orthopedics, Inc.
- BIOMET® 360 — Biomet Orthopedics, Inc.
- BIOMET® 360 INSTRUMENTS — Biomet Orthopedics, Inc.
- Biomet® — 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 bb94feda-7a1b-4189-8e08-0680b93fb470 36 fields · synced Jun 1, 2026