Cleared Traditional

K080699 - NOVEL SPINAL SPACER SYSTEM (FDA 510(k) Clearance)

K080699 · Alphatec Spine, Inc. · Orthopedic device

May 2008

Decision

70d

Days

Class 2

Risk

K080699 is an FDA 510(k) clearance for the NOVEL SPINAL SPACER SYSTEM. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).

Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 21, 2008, 70 days after receiving the submission on March 12, 2008.

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

Submission Details

510(k) Number	K080699 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 12, 2008
Decision Date	May 21, 2008
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF