510(k) K151584
K151584 is an FDA 510(k) premarket notification submitted by Progentix Orthobiology BV for the device "AttraX Putty". The FDA issued a decision of Substantially Equivalent on Oct 8, 2015. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Progentix Orthobiology BV has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 8, 2015
- Date Received
- Jun 11, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Filler, Bone Void, Calcium Compound
- Device Class
- Class II
- Regulation Number
- 888.3045
- Review Panel
- OR
- Submission Type
- 510(k)