510(k) K150649
K150649 is an FDA 510(k) premarket notification submitted by Genesis Fracture Care, Inc. for the device "G3 Active Plate Large Fragment System". The FDA issued a decision of Substantially Equivalent on Apr 30, 2015. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Genesis Fracture Care, Inc. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 30, 2015
- Date Received
- Mar 12, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)