SLR BIPOLAR HIP ENDOPROSTHESIS
FDA 510(k) clearance K861566 · decided 1986-05-12
Clearance details
- K-number
- K861566
- Device name
- SLR BIPOLAR HIP ENDOPROSTHESIS
- Applicant
- Dow Corning Wright
- Decision
- Substantially Equivalent
- Date received
- 1986-04-25
- Decision date
- 1986-05-12
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- KWY
- Device class
- 2
- Regulation number
- 888.3390
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Arlington, TN, US
- Third-party review
- No
- Expedited review
- No
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| COPAL exchange G hip spacer (K220492) | Heraeus Medical GmbH | 2022-03-23 |
| Kyocera Bipolar Hip System (K200709) | Kyocera Medical Technologies, Inc. | 2020-04-17 |
| Fitmore Hip Stem (K192236) | Zimmer GmbH | 2019-11-05 |
| COPAL exchange G Hip and Knee Spacers (K191016) | Heraeus Medical GmbH | 2019-11-01 |
| iNSitu Bipolar Hip System (K191297) | Theken Companies, LLC | 2019-09-17 |
| Implantcast ic-Bipolar Head System (K191569) | Implantcast GmbH | 2019-08-28 |
| Corin BiPolar-i (K183114) | Corin U.S.A. Limited | 2019-06-05 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS (P880076/S001) | Dow Corning Wright | 1991-06-17 |