KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY
FDA 510(k) clearance K141972 · decided 2014-10-09
Clearance details
- K-number
- K141972
- Device name
- KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY
- Applicant
- Total Joint Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-21
- Decision date
- 2014-10-09
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- OQG
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.