IMPLANET Spine System (ISS)
FDA 510(k) clearance K143731 · decided 2015-04-14
Clearance details
- K-number
- K143731
- Device name
- IMPLANET Spine System (ISS)
- Applicant
- Implanet, S.A.
- Decision
- Substantially Equivalent
- Date received
- 2014-12-29
- Decision date
- 2015-04-14
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Martillac, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.