Identity
- Trade Name
- Vanguard Knee System FDA UDI
- Generic Name
- Tibial insert FDA UDI
- Model / Reference
- EP-183448 FDA UDI
Identifiers
- Catalog Number
- EP-183448 FDA UDI
- Primary DI / UDI-DI
- 00880304465947 FDA UDI
- FDA Product Code
- JWH FDA UDIMBV FDA UDIOIY FDA UDIMBH FDA UDIHRY FDA UDI
- GMDN Term
- Tibial insert FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3565 FDA UDI888.3530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Tibial insert
Vanguard Knee System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tibial insert.
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- World Knee System — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Optetrak Logic — Exactech, Inc. · Class II
Cleared under the same submission
K080528 also covers:
- Vanguard Knee System — Biomet Orthopedics, Inc.
- Vanguard Knee System — Biomet Orthopedics, Inc.
- Vanguard Knee System — Biomet Orthopedics, Inc.
- Vanguard Knee System — Biomet Orthopedics, Inc.
- Vanguard Knee System — Biomet Orthopedics, Inc.
- Vanguard Knee System — Biomet Orthopedics, Inc.
- Vanguard Knee System — Biomet Orthopedics, Inc.
- Vanguard Knee System — Biomet Orthopedics, Inc.
- Vanguard Knee System — Biomet Orthopedics, Inc.
- Vanguard Knee System — Biomet Orthopedics, Inc.
- Vanguard Knee System — Biomet Orthopedics, Inc.
- Vanguard Knee System — Biomet Orthopedics, Inc.
K113550 also covers:
- 'VANGUARD(TM) — Biomet Orthopedics, Inc.
- 'VANGUARD(TM) — Biomet Orthopedics, Inc.
- 'VANGUARD(TM) — Biomet Orthopedics, Inc.
- BIOMET SERIES A — Biomet Orthopedics, Inc.
- Biomet® Series A™ — Biomet Orthopedics, Inc.
- Biomet® Series A™ — Biomet Orthopedics, Inc.
- Biomet® Series A™ — Biomet Orthopedics, Inc.
- Biomet® Series A™ — Biomet Orthopedics, Inc.
- VANGUARD 5-IN-1 TRIAL BEARING — Biomet Orthopedics, Inc.
- VANGUARD 5-IN-1 TRIAL BEARING — Biomet Orthopedics, Inc.
- VANGUARD GLOBAL INSTRUMENTS — Biomet Orthopedics, Inc.
- VANGUARD GLOBAL INSTRUMENTS — Biomet Orthopedics, Inc.
K171054 also covers:
- AGC Tradition Knee System — Biomet Orthopedics, Inc.
- ASCENT KNEE SYSTEM — Biomet Orthopedics, Inc.
- Ascent Knee System — Biomet Orthopedics, Inc.
- Ascent Knee System — Biomet Orthopedics, Inc.
- BIOMET KNEE SYSTEM — Biomet Orthopedics, Inc.
- BIOMET KNEE SYSTEM — Biomet Orthopedics, Inc.
- Biomet Knee System — Biomet Orthopedics, Inc.
- Biomet Knee System — Biomet Orthopedics, Inc.
- Biomet Knee System — Biomet Orthopedics, Inc.
- Biomet® Knee System — Biomet Orthopedics, Inc.
- Biomet® Knee System — Biomet Orthopedics, Inc.
- Biomet® Knee System — 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 1f0f22cf-7c5e-4a81-b293-2abcac04b3e5 36 fields · synced May 30, 2026