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FDA 510(k)

MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices

K-Number: K231231 · 2023-10-12

ApplicantParagon 28, Inc.
Decision Date2023-10-12
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2023-10-12 under approval number K231231. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices?

MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices is a medical device that received FDA 510(k) clearance on 2023-10-12. It is manufactured by Paragon 28, Inc.. The 510(k) number is K231231.

When was MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices approved by the FDA?

MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices received FDA 510(k) clearance on 2023-10-12, under approval number K231231.

What company makes MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices?

MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices is manufactured by Paragon 28, Inc..

What is the FDA product code for MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices?

The FDA product code for MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices is HWC. This falls under the Cardiovascular category.

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 42024289 Signal Detection Using Change Point Analysis to Identify Safety Signals from Spontaneous Reports in Aortic Stent Grafts in Japan. Journal of medical systems (2026) PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026)

Other Devices by Paragon 28, Inc.

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Related Devices (Code: HWC)

K161259KLS Martin Cannulated Headless ScrewsKLS Martin L.P. K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek K161597Tyber Medical BioTy® Nanotopography Trauma ScrewTyber Medical, LLC K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc. K161449HammerTech Fixation SystemFusion Orthopedics, LLC

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.

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