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Genesys Crossft, Hi-Fi, Linvatec Srs

by Conmed Corporation 9 variants

Ref CFBC-4503N

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-20845854034580 Basic UDI-DI 20845854034580UDI-DIDate10 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20845854034580 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Tendon/ligament bone anchor, bioabsorbable
Device Name
Orthopedic, Implant, Bioabsorbable, Certificate 748548
Model / Ref / Catalog
CFBC-4503N
Primary DI / UDI-DI
20845854034580
Basic UDI-DI
B-20845854034580
510(k) Number
FDA Product Code
MAI
EMDN Code
P09120102 Anchors, tendon and ligament synthesis
GMDN Term
Tendon/ligament bone anchor, bioabsorbable
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3030
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide
MRI Safety
MR Safe
Size
Outer Diameter — 4.5 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000012663
Authorised representative
MDSS GmbH DE-AR-000005430

Related devices

Category: Hand-held surgical retractor, reusable

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 (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No