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Conmed 8971S

by Conmed Corporation

Ref 8971S

Conmed 8971S is a device classified as Class IIb in the EU and Class II in the US made by Conmed Corporation, registered in EUDAMED on 13 Apr 2026 (Basic UDI-DI B-10845854015605), cleared under FDA 510(k) K933352 on 23 Feb 1994 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 10845854015605), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K933352

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10845854015605 Basic UDI-DI 10845854015605UDI-DIDate13 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10845854015605 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SN GUDID from GUDID Traditional NumberK933352 Date23 Feb 1994DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10845854015605 registered 13 Apr 2026 Active
  • FDA 510(k) K933352 decided 23 Feb 1994 Active
  • FDA GUDID UDI-DI 10845854015605 listed 24 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K933352
  2. Listed FDA GUDID 10845854015605
  3. Registered EUDAMED B-10845854015605

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Conmed
Generic name
Tendon/ligament bone anchor, non-bioabsorbable
Device name
Orthopedic, Implant, Non-absorbable, Interference Screw, Titanium, Knee, Cannulated
Model / Ref / Catalog
8971S
Primary DI / UDI-DI
10845854015605
Basic UDI-DI
B-10845854015605
510(k) Number
FDA product code
HWC
EMDN code
P09120605 Interference screws
GMDN term
Tendon/ligament bone anchor, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Length — 25 Millimeter
Outer Diameter — 7 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Tendon/ligament bone anchor, non-bioabsorbable

Cleared under the same submission (K933352)

and 8 more cleared under K933352

Similar devices in this category

Other devices filed under INTERFERENCE SCREWS.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)