B-P Total Hip System 01-16-0409
B-P Total Hip System 01-16-0409 is a Class II device made by Endotec, Inc., cleared under FDA 510(k) K905262 on 19 May 1993 and listed in FDA GUDID since 17 Sep 2015 (UDI-DI 00814193024169), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 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 | Number00814193024169 | Date17 Sep 2015 | StatusListed |
| United States | FDA 510(k)SN | NumberK905262 | Date19 May 1993 | StatusActive |
Official records
- AccessGUDID record 00814193024169
- FDA 510(k) database K905262
Across registries
- FDA 510(k) K905262 decided 19 May 1993 Active
- FDA GUDID UDI-DI 00814193024169 listed 17 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K905262
- Listed FDA GUDID 00814193024169
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- B-P Total Hip System
- Generic name
- Bipolar humeral head outer component
- Model / Ref / Catalog
- 01-16-0409
- Primary DI / UDI-DI
- 00814193024169
- 510(k) Number
- FDA product code
- JDI
- GMDN term
- Bipolar humeral head outer component
- Device class
- Class II
- Regulation number
- 888.3350
- GUDID distribution status
- Not in Commercial Distribution
- Size
- Length — 100 MillimeterWidth — 9 Millimeter