FDA.report

510(k) K153585

Device
Flip Button Suture Anchor
Applicant
FIRST RAY LLC
510(k) number
K153585
Product code
MBI  
Decision
Substantially Equivalent (SESE)
Decision date
2016-05-05
Date received
2015-12-16
Regulation
888.3040
Classification name
Fastener, Fixation, Nondegradable, Soft Tissue
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
Robert Hoy
Address
124 S. 600 W. Suite 100 Logan UT US 84321 84321

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
00815432028986SPEEDBUTTONCROSSROADS EXTREMITY SYSTEMS2021-01-22

Legacy Summary

summary

FDA Review

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