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Veritas rTSA 1500-1015

by Restor3D

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K243643

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840097513218 UDI-DI Date14 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK243643 Date19 May 2025DecidedStatusActive

Official records

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2987-2026 FDA Class II initiated 30 Jun 2026

    Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Veritas rTSA
Generic name
Total reverse shoulder prosthesis
Model / reference
1500-1015
Primary DI / UDI-DI
00840097513218
510(k) Number
FDA product code
PHX
GMDN term
Total reverse shoulder prosthesis
Device class
Class II
Regulation number
888.3660
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K243643)

Show all (12)

Other devices from Restor3D

See all devices from Restor3D →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No