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FDA 510(k)

Ligament Staple

K-Number: K210456 · 2021-04-12

ApplicantMedacta International S.A.
Decision Date2021-04-12
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ligament Staple is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2021-04-12 under 510(k) number K210456. 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 Ligament Staple?

Ligament Staple is a medical device that received FDA 510(k) clearance on 2021-04-12. The listed applicant is Medacta International S.A.. The 510(k) number is K210456.

When did Ligament Staple receive FDA 510(k) clearance?

Ligament Staple received FDA 510(k) clearance on 2021-04-12, under 510(k) number K210456.

Who is the listed applicant for Ligament Staple?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ligament Staple?

The FDA product code for Ligament Staple is JDR.

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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.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 Concepts

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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