Cleared Traditional

K883784 - TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE
(FDA 510(k) Clearance)

K883784 · Warsaw Orthopedic, Inc. · Orthopedic device

Apr 1989

Decision

212d

Days

Class 1

Risk

K883784 is an FDA 510(k) clearance for the TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE. This device is classified as a Accessories, Fixation, Spinal Intervertebral Body (Class I - General Controls, product code LYQ).

Submitted by Warsaw Orthopedic, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 6, 1989, 212 days after receiving the submission on September 6, 1988.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number	K883784 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	September 06, 1988
Decision Date	April 06, 1989
Days to Decision	212 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—