Cleared Traditional

OSTEOLOCK ACETABULAR CUP

K981201 · Howmedica Corp. · Orthopedic

May 1998

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K981201 is an FDA 510(k) clearance for the OSTEOLOCK ACETABULAR CUP, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on May 29, 1998, 57 days after receiving the submission on April 2, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K981201 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 02, 1998
Decision Date	May 29, 1998
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353