OLYMPIC Deformity Band System— 510(k) K222097
Substantially EquivalentAstura Medical
FDA 510(k) clearance K222097 for OLYMPIC Deformity Band System, Substantially Equivalent on 2023-05-04. Applicant: Astura Medical. Device class: 2.
Clearance details
- Applicant
- Astura Medical
- 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
- Irving, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.