KLASSIC HD HIP SYSTEM
FDA 510(k) clearance K100445 · decided 2010-12-03
Clearance details
- K-number
- K100445
- Device name
- KLASSIC HD HIP SYSTEM
- Applicant
- Total Joint Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-02-17
- Decision date
- 2010-12-03
- Days to decision
- 289 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.