Cleared Traditional

OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY

K984375 · Osteonics Corp. · Orthopedic
Apr 1999
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K984375 is an FDA 510(k) clearance for the OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Osteonics Corp. (Allendale,, US). The FDA issued a Cleared decision on April 30, 1999, 144 days after receiving the submission on December 7, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K984375 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 1998
Decision Date April 30, 1999
Days to Decision 144 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWP — Appliance, Fixation, Spinal Interlaminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3050

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