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FDA 510(k)

SUTURE ANCHOR

K-Number: K961578 · 1996-07-10

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1996-07-10
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1996-07-10 under 510(k) number K961578. 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 SUTURE ANCHOR?

SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 1996-07-10. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K961578.

When did SUTURE ANCHOR receive FDA 510(k) clearance?

SUTURE ANCHOR received FDA 510(k) clearance on 1996-07-10, under 510(k) number K961578.

Who is the listed applicant for SUTURE ANCHOR?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUTURE ANCHOR?

The FDA product code for SUTURE ANCHOR is JDR.

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Other records listing United States Surgical, A Division of Tyco Healthc 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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