510(k) K162133

VerteFIT Corpectomy Cage System by Ldr Spine USA, Inc. — Product Code MQP

K162133 is an FDA 510(k) premarket notification submitted by Ldr Spine USA, Inc. for the device "VerteFIT Corpectomy Cage System". The FDA issued a decision of Substantially Equivalent on May 16, 2017. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Ldr Spine USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2017
Date Received
August 1, 2016
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