Identity
- Trade Name
- Veritas rTSA FDA UDI
- Generic Name
- Total reverse shoulder prosthesis FDA UDI
- Device Name
- 4.75 mm Locking Screw, 54 mm FDA UDI
- Model / Reference
- 1504-4854 FDA UDI
- Description
- 4.75 mm Locking Screw, 54 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840097515984 FDA UDI
- 510(k) Number
- K243643 FDA UDI
- FDA Product Code
- PHX FDA UDI
- GMDN Term
- Total reverse shoulder prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Total reverse shoulder prosthesis
Veritas rTSA by Restor3D — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total reverse shoulder prosthesis.
- Anatomical Shoulder# — Zimmer, Inc. · Class II
- 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
Cleared under the same submission
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
- Restor3D
Sources (1)
- FDA UDI 7062e142-bc1b-4ffc-8205-2d1c42d60217 34 fields · synced Jun 6, 2026