510(k) K172497

NuVasive AttraX Scaffold by Nu Vasive, Incorporated — Product Code MQV

K172497 is an FDA 510(k) premarket notification submitted by Nu Vasive, Incorporated for the device "NuVasive AttraX Scaffold". The FDA issued a decision of Substantially Equivalent on Nov 24, 2017. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Nu Vasive, Incorporated has 111 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 24, 2017
Date Received
Aug 18, 2017
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)