Spinal Elements Cerclage System
FDA 510(k) clearance K180728 · decided 2018-09-06
Clearance details
- K-number
- K180728
- Device name
- Spinal Elements Cerclage System
- Applicant
- Spinal Elements, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-03-20
- Decision date
- 2018-09-06
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- OWI
- Device class
- 2
- Regulation number
- 888.3010
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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| JAZZ PF (K191217) | Implanet, S.A. | 2019-08-02 |
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Recalls involving this device
No recalls on record reference this clearance.