Cleared Traditional

Compress and Mini Compress Anti-Rotation Spindles

K183553 · Biomet, Inc. · Orthopedic

Jan 2019

Decision

33d

Days

Class 2

Risk

About This 510(k) Submission

K183553 is an FDA 510(k) clearance for the Compress and Mini Compress Anti-Rotation Spindles, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (Class II — Special Controls, product code MBF), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 22, 2019, 33 days after receiving the submission on December 20, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3670.

Submission Details

510(k) Number	K183553 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2018
Decision Date	January 22, 2019
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBF — Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3670