MICRO-SEAL ACETABULAR SYSTEM
FDA 510(k) clearance K955271 · decided 1996-01-30
Clearance details
- K-number
- K955271
- Device name
- MICRO-SEAL ACETABULAR SYSTEM
- Applicant
- Whiteside Instruments
- Decision
- Substantially Equivalent
- Date received
- 1995-11-15
- Decision date
- 1996-01-30
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Creve Coeur, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethy recall (Z-0109-2015) | Signal Medical Corporation | 2014-10-22 |