Cleared Traditional

K952495 - ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM
(FDA 510(k) Clearance)

K952495 · Orthopedic Systems, Inc. · Orthopedic

Jan 1996

Decision

237d

Days

Class 1

Risk

K952495 is an FDA 510(k) clearance for the ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM. This device is classified as a Orthopedic Manual Surgical Instrument (Class I — General Controls, product code LXH).

Submitted by Orthopedic Systems, Inc. (Union City, US). The FDA issued a Cleared decision on January 22, 1996, 237 days after receiving the submission on May 30, 1995.

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

Submission Details

510(k) Number	K952495 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 1995
Decision Date	January 22, 1996
Days to Decision	237 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement