Polarcup 75000648
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07611996116625 | Date6 Mar 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110135 | Date14 Oct 2011 | StatusActive |
Official records
- AccessGUDID record 07611996116625
- FDA 510(k) database K110135
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Polarcup
- Generic name
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Model / Ref / Catalog
- 75000648
- Primary DI / UDI-DI
- 07611996116625
- 510(k) Number
- FDA product code
- LPH
- GMDN term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device class
- Class II
- Regulation number
- 888.3358
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Other devices from Smith & Nephew, Inc.
Properties
Other properties (13)
- Supplied sterile: No
- Single use: No
- Implantable: No
- Contains latex: No
- Prescription use: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Expiration date: No
- Manufacturing date: No