510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131135Substantially Equivalent

Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis

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

K131135 is the FDA 510(k) clearance record for BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS, a class II device, cleared for Biomet Manufacturing Corp on under FDA product code MBB (Bone Cement, Antibiotic). FDA records list 128 510(k) clearances for Biomet Manufacturing Corp, from to . As of , FDA records show 5 recalls naming K131135.

Clearance record

Decision date
Received
(275 days to decision)
Product code
MBB Bone Cement, Antibiotic
Regulation
21 CFR 888.3027
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 MBB

Trailing 12 months

FDA records hold no clearances under product code MBB in the trailing twelve months.

FDA records show no clearances under product code MBB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MBB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260