Posterior Fusion Plate, HA Posterior Fusion Plate— 510(k) K200066
Substantially EquivalentSpinal Simplicity, LLC
FDA 510(k) clearance K200066 for Posterior Fusion Plate, HA Posterior Fusion Plate, Substantially Equivalent on 2020-12-10. Applicant: Spinal Simplicity, LLC. Device class: 2.
Clearance details
- Applicant
- Spinal Simplicity, LLC
- Product code
- Code PEK
- Device class
- Class 2
- Regulation
- 21 CFR 888.3050
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Overland Park, KS, US
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