Identity
- Trade Name
- Inverse/Reverse FDA UDI
- Generic Name
- Total reverse shoulder prosthesis FDA UDI
- Device Name
- Inverse/Reverse screw system, 4.5-30 FDA UDI
- Model / Reference
- 01.04223.030 FDA UDI
- Description
- Inverse/Reverse screw system, 4.5-30 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889024286009 FDA UDI
- 510(k) Number
- K052906 FDA UDI
- FDA Product Code
- KWS FDA UDIHSD FDA UDIKWT FDA UDI
- GMDN Term
- Total reverse shoulder prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3690 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.5 Millimeter FDA UDILength — 30 Millimeter FDA UDI
Category: Total reverse shoulder prosthesis
Inverse/Reverse by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total reverse shoulder prosthesis.
- Arthrex® — Arthrex, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Shoulder Innovations Inset Reverse Total Shoulder — SHOULDER INNOVATIONS, Inc · Class II
- R1 Reverse Shoulder System — CATALYST ORTHOSCIENCE Inc · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DELTA XTEND — DEPUY (IRELAND) · Class II
- Tornier Flex Shoulder System — TORNIER, INC. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
Cleared under the same submission
K052906 also covers:
- Inverse/Reverse — Zimmer, Inc.
- TM Reverse Shoulder System — Zimmer, Inc.
- TM Reverse Shoulder System — Zimmer, Inc.
- TM Reverse Shoulder System — Zimmer, Inc.
- Trabecular Metal® — Zimmer, Inc.
- Trabecular Metal® — Zimmer, Inc.
- Trabecular Metal® — Zimmer, Inc.
- Trabecular Metal® — Zimmer, Inc.
- Trabecular Metal® — Zimmer, Inc.
- Trabecular Metal® — Zimmer, Inc.
- Trabecular Metal® — Zimmer, Inc.
- Trabecular Metal® — 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 a37a618f-9f75-4887-97cc-f934123680b1 36 fields · synced May 31, 2026