Identity
- Trade Name
- CURVTEK CARTRIDGE FDA UDI
- Generic Name
- Arthroscopic shaver system handpiece, electrically-powered FDA UDI
- Model / Reference
- 906750 FDA UDI
Identifiers
- Catalog Number
- 906750 FDA UDI
- Primary DI / UDI-DI
- 00880304408128 FDA UDI
- 510(k) Number
- K972860 FDA UDI
- FDA Product Code
- HSZ FDA UDI
- GMDN Term
- Arthroscopic shaver system handpiece, electrically-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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
No
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
Category: Arthroscopic shaver system handpiece, electrically-powered
Curvtek Cartridge by Biomet Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arthroscopic shaver system handpiece, electrically-powered.
- ADVANTAGE — Conmed Corporation · Class I
- Tricera™ Handpiece, Autoclavable — RELIGN Corporation · Class II
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- ADVANTAGE — Conmed Corporation · Class I
- POWERTEK II PLUS SHAVER — Biomet Orthopedics, Inc. · Class II
- CURVTEK CARTRIDGE — Biomet Orthopedics, Inc. · Class I
- CURVTEK CARTRIDGE — Biomet Orthopedics, Inc. · Class I
Cleared under the same submission
K972860 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI d6f4c6d0-41ef-48ce-9149-2dfa1a0a714a 36 fields · synced Jun 6, 2026