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PRCT2 100-0005

by Fx Solutions

PRCT2 100-0005 is a Class II device made by Fx Solutions, cleared under FDA 510(k) K143721 on 27 Aug 2015 and listed in FDA GUDID since 9 Jun 2016 (UDI-DI 03701037301777), 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) K143721

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 Number03701037301777 UDI-DI Date9 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK143721 Date27 Aug 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K143721 decided 27 Aug 2015 Active
  • FDA GUDID UDI-DI 03701037301777 listed 9 Jun 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K143721
  2. Listed FDA GUDID 03701037301777

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PRCT2
Generic name
Total shoulder prosthesis
Model / Ref / Catalog
100-0005
Description
PRCT2, PRCT II HUMERAL PLATE TA6V RIGHT 5 HOLES
Primary DI / UDI-DI
03701037301777
510(k) Number
FDA product code
HRS
GMDN term
Total shoulder prosthesis
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Size
Length — 89.5 Millimeter

Related devices

Category: Total shoulder prosthesis

Cleared under the same submission (K143721)

and 8 more cleared under K143721

Similar devices in this category

Other devices filed under Total shoulder prosthesis.

Other devices from Fx Solutions

See all devices from Fx Solutions →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)