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

SKELETAL FIXATION PIN

K Number: K895173 · Decision Sep 12, 1989
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
93
Applicant Total
7
Review Days
33

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Basic Information

Device Name
SKELETAL FIXATION PIN
K Number
K895173
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
888.3040
Medical Specialty
Orthopedic
Decision
Substantially Equivalent
Applicant
Kronner Medical
Date Received
August 10, 1989
Decision Date
September 12, 1989
Product Code
JDW
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
JDW Pin, Fixation, Threaded

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K Number Device Name
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K895172 KRONNER SACRAL PIN GUIDE
K871248 KRONNER COLLES-FOREARM EXTERNAL FIXATION
K871249 KRONNER BI-PLANER TIBIA EXTERNAL FIXATION
K871247 KRONNER UNIVERSAL FRAME EXTERNAL FIXATION