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)

DynaFuse Fixation System

K-Number: K203595 · 2022-01-04

ApplicantMedShape, Inc.
Decision Date2022-01-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DynaFuse Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is MedShape, Inc.. It received FDA 510(k) clearance on 2022-01-04 under 510(k) number K203595. 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 DynaFuse Fixation System?

DynaFuse Fixation System is a medical device that received FDA 510(k) clearance on 2022-01-04. The listed applicant is MedShape, Inc.. The 510(k) number is K203595.

When did DynaFuse Fixation System receive FDA 510(k) clearance?

DynaFuse Fixation System received FDA 510(k) clearance on 2022-01-04, under 510(k) number K203595.

Who is the listed applicant for DynaFuse Fixation System?

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

What is the FDA product code for DynaFuse Fixation System?

The FDA product code for DynaFuse Fixation System is HWC. This falls under the Cardiovascular category.

Other records listing MedShape, 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.

K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip QuattroK250628DynaNail TTC Fusion SystemK240530DynaNail Mini Tapered HybridK220812DynaClip® Bone StapleK203381Dynanail Mini HybridK193305DynaClip Bone Staple

View all 10 devices →

Related Devices (Code: HWC)

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.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, 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.

↑