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Data / Medical devices / United States / Chest Wall Innovations, Inc.

Chest Wall Innovations, Inc.: FDA-registered device maker in Hummelstown, PA, United States, 1 510(k) clearance

Chest Wall Innovations, Inc. is registered with the FDA (registration 3044753263) in Hummelstown, PA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 24, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
3044753263
Address
1220 Wood Rd, Hummelstown, PA, United States, 17036
Owner or operator
Chest Wall Innovations, Inc. (10095864)
Roles
Specification developer
First device listed
May 12, 2026
Registered through
2026
Brand names listed
PC Fix System

Devices it lists

DeviceProduct codeClassRoleSource
Plate, Fixation, BoneHRS2Specification developeraccessdata.fda.gov
Washer, Bolt NutHTN2Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 24, 2026K260411PC Fix SystemHRSSubstantially EquivalentChest Wall Innovations, Inc.accessdata.fda.gov

Compare with other makers

Updated April 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.