FDA.reportPublic FDA data

510(k) K260411

Device
PC Fix System
Applicant
Chest Wall Innovations, Inc.
510(k) number
K260411
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-24
Date received
2026-02-09
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
N

Applicant Contact#

Contact
Kenneth Kremer
Address
710 W. Chocolate Ave., #1061 Hershey PA US 17033 17033

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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