510(k) K190283

PROSTIM Injectable Inductive Graft by Wrightmedicaltechnologyinc — Product Code MQV

K190283 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "PROSTIM Injectable Inductive Graft". The FDA issued a decision of Substantially Equivalent on March 14, 2019. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2019
Date Received
February 11, 2019
Clearance Type
Special
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