TenoLok

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref T60A75

by Conmed Corporation

Identity

Trade Name: TenoLok EUDAMED
TENOLOK, HI-FI FDA UDI
Generic Name: Arthroscopic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name: Orthopedic, Implant, Non-absorbable, Suture Anchor, PEEK, Shoulder, TenoLok Kit EUDAMED
TenoLok Tenodesis Kit with (1) 5.0 mm TenoLok Anchor with One #2 Hi-Fi Suture, (1) 2.4 mm Guide Pin, and (1) 7.0 mm Drill Bit FDA UDI
Model / Reference: T60A75 EUDAMED
T50S70 FDA UDI
Description: TenoLok Tenodesis Kit with (1) 5.0 mm TenoLok Anchor with One #2 Hi-Fi Suture, (1) 2.4 mm Guide Pin, and (1) 7.0 mm Drill Bit FDA UDI

Identifiers

Catalog Number: T50S70 FDA UDI
Primary DI / UDI-DI: 30845854044678 EUDAMEDFDA UDI
Basic UDI-DI: B-30845854044678 EUDAMED
510(k) Number: K120841 FDA UDI
FDA Product Code: MBI FDA UDI
EMDN Code: P09120102 ANCHORS, TENDON AND LIGAMENT SYNTHESIS EUDAMED
GMDN Term: Arthroscopic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Market of Registration: Belgium EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Hand-held surgical retractor, reusable

TenoLok by Conmed Corporation — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-30845854044678	Class IIb	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIb	Pending data

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Manufacturer

Manufacturer: Conmed Corporation
EUDAMED SRN: US-MF-000012663
Authorised Representative: MDSS GmbH DE-AR-000005430

Sources (2)

EUDAMED d5d0ae0a-795f-4d3c-a87b-4362578b4a0e 61 fields · synced Jun 1, 2026
FDA UDI 77211b54-9bd8-4ea4-8def-c2c9a8febd2a 37 fields · synced May 30, 2026