510(k) K221737
K221737 is an FDA 510(k) premarket notification submitted by Globus Medical, Inc. for the device "InstaFill Graft Delivery System, SIGNIFY Bioactive". The FDA issued a decision of Substantially Equivalent on Aug 11, 2022. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Globus Medical, Inc. has 173 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 11, 2022
- Date Received
- Jun 15, 2022
- 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)