Identity
- Trade Name
- TENOLOK, HI-FI FDA UDI
- Generic Name
- Arthroscopic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- TenoLok Tenodesis Kit with 5.0 mm TenoLok Anchor with One #2 Hi-Fi Suture, 2.4 mm Guide Pin, and 6.5 mm Drill Bit FDA UDI
- Model / Reference
- T50S65 FDA UDI
- Description
- TenoLok Tenodesis Kit with 5.0 mm TenoLok Anchor with One #2 Hi-Fi Suture, 2.4 mm Guide Pin, and 6.5 mm Drill Bit FDA UDI
Identifiers
- Catalog Number
- T50S65 FDA UDI
- Primary DI / UDI-DI
- 20653405987168 FDA UDI
- 510(k) Number
- K120841 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- Arthroscopic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Arthroscopic surgical procedure kit, non-medicated, single-use
Tenolok, Hi-Fi by Conmed Corporation — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Arthroscopic surgical procedure kit, non-medicated, single-use.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
Cleared under the same submission
K120841 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Conmed Corporation
Sources (2)
- FDA UDI 06440799-33f7-4b4a-a978-a92ff63ee5a0 37 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 2, 2026