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FDA 510(k)

Linkt Compression Staple System

K-Number: K250712 · 2025-05-14

ApplicantTrax Surgical
Decision Date2025-05-14
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Linkt Compression Staple System is the device name listed in this FDA 510(k) record. The listed applicant is Trax Surgical. It received FDA 510(k) clearance on 2025-05-14 under 510(k) number K250712. 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 Linkt Compression Staple System?

Linkt Compression Staple System is a medical device that received FDA 510(k) clearance on 2025-05-14. The listed applicant is Trax Surgical. The 510(k) number is K250712.

When did Linkt Compression Staple System receive FDA 510(k) clearance?

Linkt Compression Staple System received FDA 510(k) clearance on 2025-05-14, under 510(k) number K250712.

Who is the listed applicant for Linkt Compression Staple System?

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

What is the FDA product code for Linkt Compression Staple System?

The FDA product code for Linkt Compression Staple System is JDR.

Other records listing Trax Surgical 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.

K251750Trax EX AnchorK230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L

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.

K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K243888Medline 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.

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