Spinal Elements Cerclage System— 510(k) K180728
Substantially EquivalentSpinal Elements, Inc.
FDA 510(k) clearance K180728 for Spinal Elements Cerclage System, Substantially Equivalent on 2018-09-06. Applicant: Spinal Elements, Inc.. Device class: 2.
Clearance details
- Applicant
- Spinal Elements, Inc.
- Product code
- Code OWI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3010
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
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