510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K010657Substantially Equivalent

Copeland Mb Resurfacing Humeral Heads

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

K010657 is the FDA 510(k) clearance record for COPELAND MB RESURFACING HUMERAL HEADS, a class II device, cleared for Biomet Manufacturing, Inc. on under FDA product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented). FDA records list 128 510(k) clearances for Biomet Manufacturing, Inc., from to . As of , FDA records show no recalls naming K010657.

Clearance record

Decision date
Received
(192 days to decision)
Product code
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Regulation
21 CFR 888.3690
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet Manufacturing, Inc. Airport Industrial Park, Warsaw IN
510(k) summary
Summary
Third party review
No

Clearances, product code HSD

Trailing 12 months

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

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