INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET
FDA 510(k) clearance K101976 · decided 2010-09-14
Clearance details
- K-number
- K101976
- Device name
- INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET
- Applicant
- Omni Life Science, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-13
- Decision date
- 2010-09-14
- Days to decision
- 63 days
- Clearance type
- Special
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- East Taunton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.