Cleared Traditional

K151538 - NuVasive PEEK Corpectomy Railed System (FDA 510(k) Clearance)

K151538 · Nu Vasive, Incorporated · Orthopedic device

Sep 2015

Decision

88d

Days

Class 2

Risk

K151538 is an FDA 510(k) clearance for the NuVasive PEEK Corpectomy Railed System. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on September 4, 2015, 88 days after receiving the submission on June 8, 2015.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K151538 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 08, 2015
Decision Date	September 04, 2015
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF