FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

SMALL HAMMER TOE PIN

K Number: K021828 · Decision Jul 1, 2002
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
441
Review Days
27

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Basic Information

Device Name
SMALL HAMMER TOE PIN
K Number
K021828
Device Class
FDA class 2
Clearance Type
Special
Regulation Number
888.3040
Medical Specialty
Orthopedic
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Biomet, Inc.
Date Received
June 4, 2002
Decision Date
July 1, 2002
Product Code
HWC
Advisory Committee
Orthopedic
Review Advisory Committee
OR
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
HWC Screw, Fixation, Bone

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