Identity
- Trade Name
- Tenolok FDA UDI
- Generic Name
- Arthroscopic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Tenolok Tenodesis Kit With 5.0mm Tenolok Anchor with One #2 Hi-Fi Suture, 2.4mm Guide Pin, And 7.0mm Drill Bit FDA UDI
- Model / Reference
- T50S70 FDA UDI
- Description
- Tenolok Tenodesis Kit With 5.0mm Tenolok Anchor with One #2 Hi-Fi Suture, 2.4mm Guide Pin, And 7.0mm Drill Bit FDA UDI
Identifiers
- Catalog Number
- T50S70 FDA UDI
- Primary DI / UDI-DI
- 20845854044671 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
- Not 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
Ethylene Oxide FDA UDI
MR Safe FDA UDI
Tenolok by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K120841 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI 63e3c082-f2c0-4bf5-b40b-0923462d00bf 38 fields · synced Jun 8, 2026