Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Megalodon Dynamic Compression System

K-Number: K261121 · 2026-08-06

ApplicantParagon 28, Inc.
Decision Date2026-08-06
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Megalodon Dynamic Compression System is the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28, Inc.. It received FDA 510(k) clearance on 2026-08-06 under 510(k) number K261121. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Megalodon Dynamic Compression System?

Megalodon Dynamic Compression System is a medical device that received FDA 510(k) clearance on 2026-08-06. The listed applicant is Paragon 28, Inc.. The 510(k) number is K261121.

When did Megalodon Dynamic Compression System receive FDA 510(k) clearance?

Megalodon Dynamic Compression System received FDA 510(k) clearance on 2026-08-06, under 510(k) number K261121.

Who is the listed applicant for Megalodon Dynamic Compression System?

The FDA 510(k) record lists Paragon 28, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Megalodon Dynamic Compression System?

The FDA product code for Megalodon Dynamic Compression System is JDR.

Other records listing Paragon 28, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262047Grappler Suture Anchor SystemK253886Grappler Suture Anchor PCFD Tether SystemK253591Phantom® Hindfoot TTC/TC Nail SystemK253613Monkey Rings External Ring Fixation SystemK252106External Fixation Mini Rail SystemK251862External Fixation Bone Distractor

View all 56 devices →

Related Devices (Code: JDR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical ConceptsK240212COGNiTiON™ Staple SystemOrtho Solutions UK , Ltd.

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.

↑