ETEX HA HIP REPLACEMENT SYSTEM
FDA 510(k) clearance K935696 · decided 1994-07-22
Clearance details
- K-number
- K935696
- Device name
- ETEX HA HIP REPLACEMENT SYSTEM
- Applicant
- Etex Corp.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1993-11-30
- Decision date
- 1994-07-22
- Days to decision
- 234 days
- Clearance type
- Traditional
- Product code
- MEH
- Device class
- 2
- Regulation number
- 888.3353
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.