Aequalis Fx2
FDA 510(k) clearance K152966 · decided 2016-01-14
Clearance details
- K-number
- K152966
- Device name
- Aequalis Fx2
- Applicant
- Tornier S.A.S.
- Decision
- Substantially Equivalent
- Date received
- 2015-10-07
- Decision date
- 2016-01-14
- Days to decision
- 99 days
- Clearance type
- Special
- Product code
- PHX
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Montbonnot Saint Martin, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.