Cleared Traditional

OSTEONICS HA-COATED DEVICES

K980070 · Osteonics Corp. · Orthopedic

Jul 1999

Decision

561d

Days

Class 2

Risk

About This 510(k) Submission

K980070 is an FDA 510(k) clearance for the OSTEONICS HA-COATED DEVICES, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Osteonics Corp. (Allendale,, US). The FDA issued a Cleared decision on July 23, 1999, 561 days after receiving the submission on January 8, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K980070 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 08, 1998
Decision Date	July 23, 1999
Days to Decision	561 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353