Cleared Traditional

K983657 - OSTEONICS SERIES 7000 AD TIBIAL TRAY
(FDA 510(k) Clearance)

K983657 · Osteonics Corp. · Orthopedic

Apr 2000

Decision

535d

Days

Class 2

Risk

K983657 is an FDA 510(k) clearance for the OSTEONICS SERIES 7000 AD TIBIAL TRAY. This device is classified as a Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HRY).

Submitted by Osteonics Corp. (Allendale,, US). The FDA issued a Cleared decision on April 6, 2000, 535 days after receiving the submission on October 19, 1998.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3530.

Submission Details

510(k) Number	K983657 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 19, 1998
Decision Date	April 06, 2000
Days to Decision	535 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HRY — Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3530