510(k) K170271

NuVasive(r) Monolith Corpectomy System by Nu Vasive, Incorporated — Product Code MQP

K170271 is an FDA 510(k) premarket notification submitted by Nu Vasive, Incorporated for the device "NuVasive(r) Monolith Corpectomy System". The FDA issued a decision of Substantially Equivalent on Mar 30, 2017. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Nu Vasive, Incorporated has 111 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 30, 2017
Date Received
Jan 27, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type
510(k)