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CORE Shoulder System 87-9131

by LinkBio Corp.

CORE Shoulder System 87-9131 is a Class II device made by LinkBio Corp., cleared under FDA 510(k) K241470 on 20 Feb 2025 and listed in FDA GUDID since 4 Jun 2025 (UDI-DI 00810022403051), active as of 22 Oct 2026. One FDA recall is linked to it.

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) K241470

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 Number00810022403051 UDI-DI Date4 Jun 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241470 Date20 Feb 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241470 decided 20 Feb 2025 Active
  • FDA GUDID UDI-DI 00810022403051 listed 4 Jun 2025 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1810-2026 FDA Class II initiated 12 Mar 2026

    The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.

Timeline

3 dated events

  1. Cleared FDA 510(k) K241470
  2. Listed FDA GUDID 00810022403051
  3. Recall initiated FDA recalls Z-1810-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CORE Shoulder System
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / reference
87-9131
Primary DI / UDI-DI
00810022403051
510(k) Number
FDA product code
QHE, KWS, PHX
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class II
Regulation number
888.3660
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Cleared under the same submission (K241470)

and 8 more cleared under K241470

Similar devices in this category

Other devices filed under Orthopaedic prosthesis implantation positioning instrument, reusable.

Other devices from LinkBio Corp.

See all devices from LinkBio Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (12, all answered No)