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LinkStation MINI

by Orthosensor Inc 8 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816818022536 UDI-DI Date28 Apr 2021ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Arthroplasty force sensor display unit
Model / Ref / Catalog
LinkStation MINI, 05000-001-B
Primary DI / UDI-DI
00816818022536
510(k) Number
FDA Product Code
ONN
GMDN Term
Arthroplasty force sensor display unit
Device Class
Class II
Regulation Number
882.4560
GUDID distribution status
Not in Commercial Distribution

Other devices from Orthosensor Inc

See all devices from Orthosensor Inc →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No