Cleared Traditional

K873977 - NEW C-D SYSTEM FOR SPINAL SURGERY
(FDA 510(k) Clearance)

K873977 · Sofamor Co. · Orthopedic device

Dec 1987

Decision

69d

Days

Class 2

Risk

K873977 is an FDA 510(k) clearance for the NEW C-D SYSTEM FOR SPINAL SURGERY. This device is classified as a Implant, Fixation Device, Spinal (Class II - Special Controls, product code JDN).

Submitted by Sofamor Co. (Greensburg, US). The FDA issued a Cleared decision on December 7, 1987, 69 days after receiving the submission on September 29, 1987.

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

Submission Details

510(k) Number	K873977 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	September 29, 1987
Decision Date	December 07, 1987
Days to Decision	69 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—