RIGI-FIX HIP STEM SYSTEM
FDA 510(k) clearance K072101 · decided 2007-11-19
Clearance details
- K-number
- K072101
- Device name
- RIGI-FIX HIP STEM SYSTEM
- Applicant
- Implants Intl. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2007-07-31
- Decision date
- 2007-11-19
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Thornaby-On-Tees, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.