Polarcup 75000662
Polarcup 75000662 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 07611996116762), 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 | Number07611996116762 | Date22 May 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110135 | Date14 Oct 2011 | StatusActive |
Official records
- AccessGUDID record 07611996116762
- FDA 510(k) database K110135
Across registries
- FDA 510(k) K110135 decided 14 Oct 2011 Active
- FDA GUDID UDI-DI 07611996116762 listed 22 May 2017 Listed
Timeline
- Cleared FDA 510(k) K110135
- Listed FDA GUDID 07611996116762
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- Withdrawn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
- 75000662
- Primary DI / UDI-DI
- 07611996116762
- 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
Similar devices in this category
Other devices filed under Acetabulum prosthesis trial, prefabricated, reusable.
- Continuum® Trilogy® Allofit® 00-8731-016-36 by Zimmer, Inc.
- Trilogy® Longevity® 00-6144-076-36 by Zimmer, Inc.
- TRIAL CUP D52 mm H0030153009 by HPF SRL
- Trinity Acetabular Hip System with HXLPE Liners 921.04.640 by CORIN LTD
- G7® 010002641 by Biomet Orthopedics, Inc.
- G7® 010002634 by Biomet Orthopedics, Inc.
- TRIAL CUP D43 mm 9055.28.443 by HPF SRL
- MobiliT Cup MDM160 by CORIN LTD