Identity
- Trade Name
- Anatomical Shoulder™ Domelock® FDA UDI
- Generic Name
- Humeral head prosthesis trial, reusable FDA UDI
- Device Name
- TRIAL HEAD 46-19 FDA UDI
- Model / Reference
- 01.04558.217 FDA UDI
- Description
- TRIAL HEAD 46-19 FDA UDI
Identifiers
- Catalog Number
- 01.04558.217 FDA UDI
- Primary DI / UDI-DI
- 00889024275768 FDA UDI
- 510(k) Number
- K142403 FDA UDI
- FDA Product Code
- KWS FDA UDIKWT FDA UDIHSD FDA UDIPHX FDA UDI
- GMDN Term
- Humeral head prosthesis trial, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3650 FDA UDI888.3690 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Humeral head prosthesis trial, reusable
Anatomical Shoulder™ Domelock® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Humeral head prosthesis trial, reusable.
- AETOS Shoulder System — Smith & Nephew, Inc. · Class I
- BIO-MODULAR — Biomet Orthopedics, Inc. · Class II
- Made-To-Order — TORNIER, INC. · Class I
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc. · Class II
- BIO-MODULAR CHOICE INSTRUMENTS — Biomet Orthopedics, Inc. · Class I
- NEER — Smith & Nephew, Inc. · Class I
- Aequalis Reversed II — TORNIER, INC. · Class I
- SMR Shoulder — Limacorporate · Class II
Cleared under the same submission
K142403 also covers:
- Anatomical Shoulder™ — Zimmer, Inc.
- Anatomical Shoulder™ — Zimmer, Inc.
- Anatomical Shoulder™ — Zimmer, Inc.
- Anatomical Shoulder™ — Zimmer, Inc.
- Anatomical Shoulder™ — Zimmer, Inc.
- Anatomical Shoulder™ — Zimmer, Inc.
- Anatomical Shoulder™ — Zimmer, Inc.
- Anatomical Shoulder™ — Zimmer, Inc.
- Anatomical Shoulder™ — Zimmer, Inc.
- Anatomical Shoulder™ — Zimmer, Inc.
- Anatomical Shoulder™ — Zimmer, Inc.
- Anatomical Shoulder™ — 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 5b86618b-f7de-4b15-99f6-b63245c54b48 36 fields · synced May 31, 2026