FDA.report

510(k) K151692

Device
BioArchitects Patient Specific Cranial/Craniofacial Plate
Applicant
BioArchitects USA, LLC
510(k) number
K151692
Product code
GXN  
Decision
Substantially Equivalent (SESE)
Decision date
2015-11-20
Date received
2015-06-23
Regulation
882.5330
Classification name
Plate, Cranioplasty, Preformed, Non-alterable
Medical specialty
Neurology
Review panel
Neurology
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
Mark E. Ulrich
Address
219 E. 69th St. Suite 2k New York NY US 10021 10021

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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