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endophix MS-2166-25

by Suzhou Endophix Co., Ltd.

Listed FDA GUDID listing, no authorization on record

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 Number06974940305713 UDI-DI Date28 Apr 2026ListedStatusListed GUDID: 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  • Withdrawn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

Trade Name
endophix
Generic Name
Tendon/ligament bone anchor, non-bioabsorbable
Model / Reference
MS-2166-25
Primary DI / UDI-DI
06974940305713
510(k) Number
FDA Product Code
MBI, HTN
GMDN Term
Tendon/ligament bone anchor, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3040, 888.3030
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K232941)

Show all (12)

Other devices from Suzhou Endophix Co., Ltd.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No