DJO Acetabular System
FDA 510(k) clearance K190057 · decided 2019-06-07
Clearance details
- K-number
- K190057
- Device name
- DJO Acetabular System
- Applicant
- Encore Medical L.P.
- Decision
- Substantially Equivalent
- Date received
- 2019-01-11
- Decision date
- 2019-06-07
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 d recall (Z-1234-2026) | Encore Medical, LP | 2026-02-02 |
| EMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF: 942-01-40H recall (Z-0103-2024) | Encore Medical, LP | 2023-10-12 |
| EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic impl recall (Z-0125-2023) | Encore Medical, LP | 2022-10-21 |