FDA.reportPublic FDA data

510(k) K003428

Device
Iss Offset Heads
Applicant
BIOMET, INC.
510(k) number
K003428
Product code
HSD
Decision
Substantially Equivalent (SESE)
Decision date
2000-11-24
Date received
2000-11-03
Regulation
888.3690
Classification name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DALENE T BINKLEY
Address
Airport Industrial Park P.O. Box 587 Warsaw IN US 46581 46581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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