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Pressft, Hi-Fi

by Conmed Corporation 6 variants

Ref NP261H

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

6 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-20845854036645 Basic UDI-DI 20845854036645UDI-DIDate14 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20845854036645 UDI-DI Date24 Oct 2015ListedStatusListed 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

6 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-0066-2013 FDA Class II initiated 26 Jun 2012
    • Terminated Z-0068-2013 FDA Class II initiated 26 Jun 2012
    • Terminated Z-0067-2013 FDA Class II initiated 26 Jun 2012
    • Terminated Z-0064-2013 FDA Class II initiated 26 Jun 2012
    • Terminated Z-0063-2013 FDA Class II initiated 26 Jun 2012

    Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant.

    • Terminated Z-0065-2013 FDA Class II initiated 26 Jun 2012

    Linvatec Corporation DBA ConMed Linvatec in Largo, FL is recalling Press FT HI-FI Sutures (items NP 211, NP 212, NP 261, NP 262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant.

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  • Withdrawn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, non-bioabsorbable
Device Name
Orthopedic, Implant, Non-absorbable, Suture Anchor, PEEK, Shoulder and Hip
Model / Ref / Catalog
NP261H
Primary DI / UDI-DI
20845854036645
Basic UDI-DI
B-20845854036645
510(k) Number
FDA Product Code
MBI
EMDN Code
P09120102 Anchors, tendon and ligament synthesis
GMDN Term
Tendon/ligament bone anchor, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3040
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
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