Veritas rTSA

FDA UDI

Class II (US FDA UDI)

by Restor3D

Identity

Trade Name: Veritas rTSA FDA UDI
Generic Name: Total reverse shoulder prosthesis FDA UDI
Device Name: 00840097515892 FDA UDI
Model / Reference: 1504-4818 FDA UDI
Description: 00840097515892 FDA UDI

Identifiers

Primary DI / UDI-DI: 00840097515892 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe 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

K243643 also covers:

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 b67ae986-49be-40ba-b39a-8b77d356c67f 34 fields · synced May 30, 2026