510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193038Substantially Equivalent

Comprehensive Shoulder System

Biomet Manufacturing Corp, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193038 is the FDA 510(k) clearance record for Comprehensive Shoulder System, a class II device, cleared for Biomet Manufacturing Corp on under FDA product code MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented). FDA records list 128 510(k) clearances for Biomet Manufacturing Corp, from to . As of , FDA records show one recall naming K193038.

Clearance record

Decision date
Received
(363 days to decision)
Product code
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Regulation
21 CFR 888.3670
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet Manufacturing Corp 56 E. Bell Dr., Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBF

Trailing 12 months
1 clearance under product code MBF in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MBF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260