FDA.report

510(k) K131264

Device
KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS
Applicant
GEBR. BRASSELER GMBH & CO. KG
510(k) number
K131264
Product code
HWC  
Decision
Substantially Equivalent (SESE)
Decision date
2013-07-26
Date received
2013-05-03
Regulation
888.3040
Classification name
Screw, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ERELA DANA
Address
1331 H St. NW 12th Floor Washington DC US 20005 20005

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

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Legacy Summary

summary

FDA Review

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