Cleared Traditional

K013222 - SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM
(FDA 510(k) Clearance)

K013222 · Depuyacromed · Orthopedic

Nov 2001

Decision

41d

Days

Class 2

Risk

K013222 is an FDA 510(k) clearance for the SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM, a Orthosis, Spinal Pedicle Fixation (Class II — Special Controls, product code MNI), submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on November 7, 2001, 41 days after receiving the submission on September 27, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K013222 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2001
Decision Date	November 07, 2001
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF