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FDA 510(k)

ARTHREX STAPLES

K-Number: K943492 · 1995-02-01

ApplicantArthrex, Inc.
Decision Date1995-02-01
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ARTHREX STAPLES is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 1995-02-01 under 510(k) number K943492. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ARTHREX STAPLES?

ARTHREX STAPLES is a medical device that received FDA 510(k) clearance on 1995-02-01. The listed applicant is Arthrex, Inc.. The 510(k) number is K943492.

When did ARTHREX STAPLES receive FDA 510(k) clearance?

ARTHREX STAPLES received FDA 510(k) clearance on 1995-02-01, under 510(k) number K943492.

Who is the listed applicant for ARTHREX STAPLES?

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

What is the FDA product code for ARTHREX STAPLES?

The FDA product code for ARTHREX STAPLES is JDR.

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Other records listing Arthrex, 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.

K262975Arthrex Beaming SystemK262618Arthrex Spine Compression FT ScrewK262451Arthrex DynaNite StaplesK262357Arthrex Bioabsorbable PushLock Suture AnchorsK260624Arthrex Radial Head Replacement SystemK260018Arthrex FiberButton

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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.

K262451Arthrex DynaNite StaplesArthrex, Inc.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 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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