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)

Treace Medical Concepts (TMC) Snap-Off Screw System

K-Number: K183363 · 2019-06-13

ApplicantTreace Medical Concepts, Inc.
Decision Date2019-06-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Treace Medical Concepts (TMC) Snap-Off Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical Concepts, Inc.. It received FDA 510(k) clearance on 2019-06-13 under 510(k) number K183363. 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 Treace Medical Concepts (TMC) Snap-Off Screw System?

Treace Medical Concepts (TMC) Snap-Off Screw System is a medical device that received FDA 510(k) clearance on 2019-06-13. The listed applicant is Treace Medical Concepts, Inc.. The 510(k) number is K183363.

When did Treace Medical Concepts (TMC) Snap-Off Screw System receive FDA 510(k) clearance?

Treace Medical Concepts (TMC) Snap-Off Screw System received FDA 510(k) clearance on 2019-06-13, under 510(k) number K183363.

Who is the listed applicant for Treace Medical Concepts (TMC) Snap-Off Screw System?

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

What is the FDA product code for Treace Medical Concepts (TMC) Snap-Off Screw System?

The FDA product code for Treace Medical Concepts (TMC) Snap-Off Screw System is HWC. This falls under the Cardiovascular category.

Other records listing Treace Medical Concepts, 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.

K260361Treace Medical Concepts (TMC) Screw Fixation SystemK251135Treace Medical Concepts (TMC) Implant Fixation SystemK243658TMC Compression Implant SystemK242671Treace Medical Concepts (TMC) Screw Fixation SystemK242415TMC Compression Implant SystemK240173Treace Medical Systems (TMC) Plating System

View all 19 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.

↑