Stryker Orthopaedics Hip Systems Labeling Update
FDA 510(k) clearance K153345 · decided 2016-05-25
Clearance details
- K-number
- K153345
- Device name
- Stryker Orthopaedics Hip Systems Labeling Update
- Applicant
- Stryker Orthopaedics
- Decision
- Substantially Equivalent
- Date received
- 2015-11-19
- Decision date
- 2016-05-25
- Days to decision
- 188 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mahwah, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Ster recall (Z-0060-2017) | Stryker Howmedica Osteonics Corp. | 2016-10-07 |