Fusion Silastic System— 510(k) K190136
Substantially EquivalentFusion Orthopedics, LLC
FDA 510(k) clearance K190136 for Fusion Silastic System, Substantially Equivalent on 2019-10-21. Applicant: Fusion Orthopedics, LLC. Device class: 2.
Clearance details
- Applicant
- Fusion Orthopedics, LLC
- Product code
- Code KWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3720
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mesa, AZ, US
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