Cleared Traditional

K200959 - Biolox? delta Ceramic Heads, Biolox? delta Option Ceramic Heads MR Labeling
(FDA 510(k) Clearance)

K200959 · Biomet UK, Ltd. · Orthopedic

Jul 2020

Decision

110d

Days

Class 2

Risk

K200959 is an FDA 510(k) clearance for the Biolox? delta Ceramic Heads, Biolox? delta Option Ceramic Heads MR Labeling, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Biomet UK, Ltd. (Brigend, GB). The FDA issued a Cleared decision on July 29, 2020, 110 days after receiving the submission on April 10, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K200959 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 2020
Decision Date	July 29, 2020
Days to Decision	110 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