510(k) K200606
K200606 is an FDA 510(k) premarket notification submitted by Orthofix, Inc. for the device "O-Genesis Graft Delivery System". The FDA issued a decision of Substantially Equivalent on May 1, 2020. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Orthofix, Inc. has 97 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 2020
- Date Received
- Mar 9, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
- 510(k)