Identity
- Trade Name
- Vanguard® Vivacit-E® FDA UDI
- Generic Name
- Tibial insert FDA UDI
- Model / Reference
- VE183506 FDA UDI
Identifiers
- Catalog Number
- VE183506 FDA UDI
- Primary DI / UDI-DI
- 00889024565241 FDA UDI
- 510(k) Number
- K183583 FDA UDI
- FDA Product Code
- JWH FDA UDIOIY FDA UDIMBH FDA UDI
- GMDN Term
- Tibial insert FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3565 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
Dimensions & Sizes
- Size
- Width — 59.00 Millimeter FDA UDI
Category: Tibial insert
Vanguard® Vivacit-E® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K183583 also covers:
- Vanguard® Vivacit-E® — Zimmer, Inc.
- Vanguard® Vivacit-E® — Zimmer, Inc.
- Vanguard® Vivacit-E® — Zimmer, Inc.
- Vanguard® Vivacit-E® — Zimmer, Inc.
- Vanguard® Vivacit-E® — Zimmer, Inc.
- Vanguard® Vivacit-E® — Zimmer, Inc.
- Vanguard® Vivacit-E® — Zimmer, Inc.
- Vanguard® Vivacit-E® — Zimmer, Inc.
- Vanguard® Vivacit-E® — Zimmer, Inc.
- Vanguard® Vivacit-E® — Zimmer, Inc.
- Vanguard® Vivacit-E® — Zimmer, Inc.
- Vanguard® Vivacit-E® — Zimmer, 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
- Zimmer, Inc.
Sources (1)
- FDA UDI 7277acbc-2aa4-47ec-ad6c-786b5702f29e 36 fields · synced May 30, 2026