Cleared Traditional

K871323 - ARTHROSCOPIC MENISCAL SUTURE SYSTEM
(FDA 510(k) Clearance)

K871323 · Orthopedic Systems, Inc. · Orthopedic device

May 1987

Decision

28d

Days

Class 1

Risk

K871323 is an FDA 510(k) clearance for the ARTHROSCOPIC MENISCAL SUTURE SYSTEM. This device is classified as a Template (Class I - General Controls, product code HWT).

Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on May 1, 1987, 28 days after receiving the submission on April 3, 1987.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4800.

Submission Details

510(k) Number	K871323 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 03, 1987
Decision Date	May 01, 1987
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—