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GENESYS™ CrossFT™ CFBC-4503R

by Conmed Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

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 Number20653405990915 UDI-DI Date31 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-3018-2026 FDA Class II initiated 14 Jul 2026

    Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.

    • Terminated Z-1619-2013 FDA Class II initiated 6 Mar 2013

    Incorrect blue/white suture was used.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
GENESYS™ CrossFT™
Generic Name
Tendon/ligament bone anchor, bioabsorbable
Model / Ref / Catalog
CFBC-4503R
Primary DI / UDI-DI
20653405990915
510(k) Number
FDA Product Code
MAI
GMDN Term
Tendon/ligament bone anchor, bioabsorbable
Device Class
Class II
Regulation Number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide
MRI Safety
MR Safe
Size
Outer Diameter — 1.3 Millimeter
Outer Diameter — 4.5 Millimeter

Related devices

Cleared under the same submission (K101100)

Show all (12)

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

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

Other properties (8)

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