FDA.report

510(k) K051747

Device
SBI WRISTFIT
Applicant
SMALL BONE INNOVATIONS, LLC
510(k) number
K051747
Product code
HRS  
Decision
Substantially Equivalent (SESE)
Decision date
2005-09-06
Date received
2005-06-29
Regulation
888.3030
Classification name
Plate, 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
DONALD GUTHNER
Address
505 Park Ave. 14th Floor New York NY US 10022 10022

FDA Registration Numbers

Source Documents

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

Legacy Summary

summary

FDA Review

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