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FDA 510(k)

CAIS STAPLE

K-Number: K073281 · 2008-05-02

ApplicantDepuy Mitek, A Johnson & Johnson Company
Decision Date2008-05-02
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CAIS STAPLE is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. It received FDA 510(k) clearance on 2008-05-02 under 510(k) number K073281. 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 CAIS STAPLE?

CAIS STAPLE is a medical device that received FDA 510(k) clearance on 2008-05-02. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. The 510(k) number is K073281.

When did CAIS STAPLE receive FDA 510(k) clearance?

CAIS STAPLE received FDA 510(k) clearance on 2008-05-02, under 510(k) number K073281.

Who is the listed applicant for CAIS STAPLE?

The FDA 510(k) record lists Depuy Mitek, A Johnson & Johnson Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAIS STAPLE?

The FDA product code for CAIS STAPLE is JDR.

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Other records listing Depuy Mitek, A Johnson & Johnson Company 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.

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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