Cleared Traditional

K760649 - TOTAL SPINAL CORRECTION
(FDA 510(k) Clearance)

K760649 · Depuy, Inc. · Orthopedic device

Oct 1976

Decision

20d

Days

Class 2

Risk

K760649 is an FDA 510(k) clearance for the TOTAL SPINAL CORRECTION. This device is classified as a Implant, Fixation Device, Spinal (Class II - Special Controls, product code JDN).

Submitted by Depuy, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 5, 1976, 20 days after receiving the submission on September 15, 1976.

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

Submission Details

510(k) Number	K760649 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 15, 1976
Decision Date	October 05, 1976
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—