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Tenolok, Hi-Fi

by Conmed Corporation 2 variants

Ref T50S, T50S70, T60S75

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

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-30845854043787 Basic UDI-DI Date27 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30845854043787 UDI-DI Date11 Feb 2021ListedStatusListed 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

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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

Trade Name
Tenolok, Hi-Fi EUDAMEDGUDID
TenoLok GUDID
Generic Name
Arthroscopic surgical procedure kit, non-medicated, single-use
Tendon/ligament bone anchor, non-bioabsorbable
Device Name
Orthopedic, Implant, Non-absorbable, Suture Anchor, PEEK, Shoulder TenoLok
Orthopedic, Implant, Non-absorbable, Suture Anchor, PEEK, Shoulder, TenoLok Kit
Model / Ref / Catalog
T50S, T50S70, T60S75, T60A75
Primary DI / UDI-DI
30845854043787, 20653405987199, 20653405987182
Basic UDI-DI
B-30845854043787, B-20653405987199, B-20653405987182
510(k) Number
FDA Product Code
MBI
EMDN Code
P09120102 Anchors, tendon and ligament synthesis
GMDN Term
Arthroscopic surgical procedure kit, non-medicated, single-use
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
Sterilization Method
Ethylene Oxide
MRI Safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
Yes
No

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 YesEUDAMEDGUDIDNoGUDID
  • Prescription Use
  • Convenience Kit YesGUDIDNoGUDID
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No