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LINK Embrace Shoulder System 645-080/56

by WALDEMAR LINK GmbH & Co. KG

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

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 Number04026575280872 UDI-DI Date30 Mar 2021ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
LINK Embrace Shoulder System
Generic Name
Orthopaedic implant impactor, reusable
Model / Ref / Catalog
645-080/56
Primary DI / UDI-DI
04026575280872
510(k) Number
FDA Product Code
HSD, PAO, PHX
GMDN Term
Orthopaedic implant impactor, reusable
Device Class
Class II
Regulation Number
888.3690, 888.3660
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implant impactor, reusable

Cleared under the same submission (K200368)

Show all (12)

Other devices from WALDEMAR LINK GmbH & Co. KG

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • 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
  • Serial Number: No
  • Expiration Date: No