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CoNextions TR Tendon Repair System-Implant Mechanism FA0004

by Conextions Medical

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 Number00861445000327 UDI-DI Date28 Apr 2022ListedStatusListed 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  • Withdrawn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
CoNextions TR Tendon Repair System-Implant Mechanism
Generic Name
Tendon coaptation implant
Model / Ref / Catalog
FA0004
Primary DI / UDI-DI
00861445000327
510(k) Number
FDA Product Code
GAQ
GMDN Term
Tendon coaptation implant
Device Class
Class II
Regulation Number
878.4495
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Tendon coaptation implant

Cleared under the same submission (K203855)

Other devices from Conextions Medical

Properties

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

Other properties (7)

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