OLYMPIC Posterior Spinal Fixation System— 510(k) K153446
Substantially EquivalentAstura Medical
FDA 510(k) clearance K153446 for OLYMPIC Posterior Spinal Fixation System, Substantially Equivalent on 2016-04-08. Applicant: Astura Medical. Device class: 2.
Clearance details
- Applicant
- Astura Medical
- Product code
- Code OSH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code OSH
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Data sourced from openFDA. This site is unofficial and independent of the FDA.