Polarcup 75000656
Polarcup 75000656 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K110135 on 14 Oct 2011 and listed in FDA GUDID since 22 May 2017 (UDI-DI 07611996116700), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07611996116700 | Date22 May 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110135 | Date14 Oct 2011 | StatusActive |
Official records
- AccessGUDID record 07611996116700
- FDA 510(k) database K110135
Across registries
- FDA 510(k) K110135 decided 14 Oct 2011 Active
- FDA GUDID UDI-DI 07611996116700 listed 22 May 2017 Listed
Timeline
- Cleared FDA 510(k) K110135
- Listed FDA GUDID 07611996116700
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Polarcup
- Generic name
- Acetabulum prosthesis trial, prefabricated, reusable
- Model / Ref / Catalog
- 75000656
- Primary DI / UDI-DI
- 07611996116700
- 510(k) Number
- FDA product code
- LPH
- GMDN term
- Acetabulum prosthesis trial, prefabricated, reusable
- Device class
- Class II
- Regulation number
- 888.3358
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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