Cleared Traditional

OSTEONICS FX-CABLELOK GRIP COMPONENTS

K980594 · Osteonics Corp. · Orthopedic
May 1998
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K980594 is an FDA 510(k) clearance for the OSTEONICS FX-CABLELOK GRIP COMPONENTS, a Fixation Accessory (Class II — Special Controls, product code LYT), submitted by Osteonics Corp. (Allendale,, US). The FDA issued a Cleared decision on May 5, 1998, 77 days after receiving the submission on February 17, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K980594 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 1998
Decision Date May 05, 1998
Days to Decision 77 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LYT — Fixation Accessory
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030