FIXION HIP SYSTEM
FDA 510(k) clearance K032730 · decided 2004-03-26
Clearance details
- K-number
- K032730
- Device name
- FIXION HIP SYSTEM
- Applicant
- Disc-O-Tech Medical Technologies, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-03
- Decision date
- 2004-03-26
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- JDI
- Device class
- 2
- Regulation number
- 888.3350
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Herzelia, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.