FDA.report

510(k) K151382

Device
Patient Contoured Implant-PEEK (PCI-PEEK)
Applicant
KLS MARTIN L.P.
510(k) number
K151382
Product code
GXN  
Decision
Substantially Equivalent (SESE)
Decision date
2015-11-09
Date received
2015-05-22
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
JENNIFER DAMATO
Address
11201 Saint Johns Industrial Pkwy. S Jacksonville FL US 32246 32246

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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