Cleared Traditional

BIOLOX delta Option and Extra-long Heads

K173776 · Microport Orthopedics, Inc. · Orthopedic
Jul 2018
Decision
206d
Days
Class 2
Risk

About This 510(k) Submission

K173776 is an FDA 510(k) clearance for the BIOLOX delta Option and Extra-long Heads, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on July 6, 2018, 206 days after receiving the submission on December 12, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number K173776 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2017
Decision Date July 06, 2018
Days to Decision 206 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

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