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FDA 510(k)

NITINEX Memory Compression Staple

K-Number: K231493 · 2023-08-11

ApplicantVilex, LLC
Decision Date2023-08-11
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NITINEX Memory Compression Staple is the device name listed in this FDA 510(k) record. The listed applicant is Vilex, LLC. It received FDA 510(k) clearance on 2023-08-11 under 510(k) number K231493. 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 NITINEX Memory Compression Staple?

NITINEX Memory Compression Staple is a medical device that received FDA 510(k) clearance on 2023-08-11. The listed applicant is Vilex, LLC. The 510(k) number is K231493.

When did NITINEX Memory Compression Staple receive FDA 510(k) clearance?

NITINEX Memory Compression Staple received FDA 510(k) clearance on 2023-08-11, under 510(k) number K231493.

Who is the listed applicant for NITINEX Memory Compression Staple?

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

What is the FDA product code for NITINEX Memory Compression Staple?

The FDA product code for NITINEX Memory Compression Staple is JDR.

Other records listing Vilex, LLC as applicant

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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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