Response BandLoc Spinal Fixation— 510(k) K200097
Substantially EquivalentOrthoPediatrics Corp.
FDA 510(k) clearance K200097 for Response BandLoc Spinal Fixation, Substantially Equivalent on 2020-03-16. Applicant: OrthoPediatrics Corp.. Device class: 2.
Clearance details
- Applicant
- OrthoPediatrics Corp.
- 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
- Warsaw, IN, US
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