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FDA 510(k)

Memodyn Staple

K-Number: K161587 · 2017-02-01

ApplicantAustin & Associates, Inc./Telos Medical Equipment
Decision Date2017-02-01
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Memodyn Staple is the device name listed in this FDA 510(k) record. The listed applicant is Austin & Associates, Inc./Telos Medical Equipment. It received FDA 510(k) clearance on 2017-02-01 under 510(k) number K161587. 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 Memodyn Staple?

Memodyn Staple is a medical device that received FDA 510(k) clearance on 2017-02-01. The listed applicant is Austin & Associates, Inc./Telos Medical Equipment. The 510(k) number is K161587.

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

Memodyn Staple received FDA 510(k) clearance on 2017-02-01, under 510(k) number K161587.

Who is the listed applicant for Memodyn Staple?

The FDA 510(k) record lists Austin & Associates, Inc./Telos Medical Equipment as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Memodyn Staple?

The FDA product code for Memodyn Staple is JDR.

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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