Identity
- Trade Name
- Comprehensive® Vivacit-E® FDA UDI
- Generic Name
- Polyethylene reverse shoulder prosthesis cup FDA UDI
- Model / Reference
- 110031428 FDA UDI
Identifiers
- Catalog Number
- 110031428 FDA UDI
- Primary DI / UDI-DI
- 00887868231599 FDA UDI
- 510(k) Number
- K181611 FDA UDI
- FDA Product Code
- PAO FDA UDIKWS FDA UDIPHX FDA UDIKWT FDA UDI
- GMDN Term
- Polyethylene reverse shoulder prosthesis cup FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3650 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: Polyethylene reverse shoulder prosthesis cup
Comprehensive® Vivacit-E® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyethylene reverse shoulder prosthesis cup.
- PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
- PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
- PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
- FX V135 Shoulder Prosthesis — FX SOLUTIONS · Class II
- TORNIER PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
- Equinoxe® — Exactech, Inc. · Class II
- Tornier Perform Humeral System — TORNIER, INC. · Class II
- PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
Cleared under the same submission
K181611 also covers:
- MODIFIED MINI MASTER TRAY PROVISIONAL — Biomet Orthopedics, Inc.
- MODIFIED MINI TRAY +10 0MM OFFSET — Biomet Orthopedics, Inc.
- MODIFIED MINI TRAY +10 3MM OFFSET — Biomet Orthopedics, Inc.
- MODIFIED MINI TRAY +10 6MM OFFSET — Biomet Orthopedics, Inc.
- MODIFIED MINI TRAY +5 0MM OFFSET — Biomet Orthopedics, Inc.
- MODIFIED MINI TRAY +5 3MM OFFSET — Biomet Orthopedics, Inc.
- MODIFIED MINI TRAY +5 6MM OFFSET — Biomet Orthopedics, Inc.
- MODIFIED MINI TRAY 6MM OFFSET — Biomet Orthopedics, Inc.
- MODIFIED MINI TRAY STD 0MM OFFSET — Biomet Orthopedics, Inc.
- MODIFIED MINI TRAY STD 3MM OFFSET — Biomet Orthopedics, Inc.
- Comprehensive® — Zimmer, Inc.
- Comprehensive® — 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 1a6572ff-3162-4212-889b-a8e8e375a946 36 fields · synced Jun 6, 2026