PC Fix System
K-Number: K260411 · 2026-04-24
ApplicantChest Wall Innovations, Inc.
Decision Date2026-04-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
PC Fix System is a medical device manufactured by Chest Wall Innovations, Inc.. It received FDA 510(k) clearance on 2026-04-24 under approval number K260411. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PC Fix System?
PC Fix System is a medical device that received FDA 510(k) clearance on 2026-04-24. It is manufactured by Chest Wall Innovations, Inc.. The 510(k) number is K260411.
When was PC Fix System approved by the FDA?
PC Fix System received FDA 510(k) clearance on 2026-04-24, under approval number K260411.
What company makes PC Fix System?
PC Fix System is manufactured by Chest Wall Innovations, Inc..
What is the FDA product code for PC Fix System?
The FDA product code for PC Fix System is HRS.
Related Devices (Code: HRS)
K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.
K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.
K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation
K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation
K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG
K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.