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FDA 510(k)

MULTITAK SS SUTURE SYSTEM

K-Number: K964532 · 1997-02-03

ApplicantBonutti Research
Decision Date1997-02-03
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MULTITAK SS SUTURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bonutti Research. It received FDA 510(k) clearance on 1997-02-03 under 510(k) number K964532. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTITAK SS SUTURE SYSTEM?

MULTITAK SS SUTURE SYSTEM is a medical device that received FDA 510(k) clearance on 1997-02-03. The listed applicant is Bonutti Research. The 510(k) number is K964532.

When did MULTITAK SS SUTURE SYSTEM receive FDA 510(k) clearance?

MULTITAK SS SUTURE SYSTEM received FDA 510(k) clearance on 1997-02-03, under 510(k) number K964532.

Who is the listed applicant for MULTITAK SS SUTURE SYSTEM?

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

What is the FDA product code for MULTITAK SS SUTURE SYSTEM?

The FDA product code for MULTITAK SS SUTURE SYSTEM is MBI.

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Other records listing Bonutti Research 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.

K990156MULTITAK SS BUTTONSK973015MULTITAK SS SUTURE SYSTEMK971144MULTITAK SS SUTURE SYSTEMK964324MULTITAK SS SUTURE SYSTEM

Related Devices (Code: MBI)

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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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