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REDEMPTION Beaming System RPT50-50T-15

by Vilex, Inc.

REDEMPTION Beaming System RPT50-50T-15 is a Class II device made by Vilex, Inc., cleared under FDA 510(k) K221342 on 13 Dec 2022 and listed in FDA GUDID since 16 Apr 2026 (UDI-DI 00841731132222), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K221342

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841731132222 UDI-DI Date16 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK221342 Date13 Dec 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K221342 decided 13 Dec 2022 Active
  • FDA GUDID UDI-DI 00841731132222 listed 16 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K221342
  2. Listed FDA GUDID 00841731132222

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
REDEMPTION Beaming System
Generic name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
RPT50-50T-15
Primary DI / UDI-DI
00841731132222
510(k) Number
FDA product code
HWC
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Vilex, Inc.

See all devices from Vilex, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)