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FDA 510(k)

FASTAK SUTURE ANCHOR

K-Number: K960516 · 1996-04-18

ApplicantArthrex, Inc.
Decision Date1996-04-18
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

FASTAK SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 1996-04-18 under 510(k) number K960516. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the FASTAK SUTURE ANCHOR?

FASTAK SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 1996-04-18. The listed applicant is Arthrex, Inc.. The 510(k) number is K960516.

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

FASTAK SUTURE ANCHOR received FDA 510(k) clearance on 1996-04-18, under 510(k) number K960516.

Who is the listed applicant for FASTAK SUTURE ANCHOR?

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 FASTAK SUTURE ANCHOR?

The FDA product code for FASTAK SUTURE ANCHOR is MBI.

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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.

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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

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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