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FDA 510(k)

FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)

K-Number: K971723 · 1997-07-30

ApplicantArthrex, Inc.
Decision Date1997-07-30
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM) is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 1997-07-30 under 510(k) number K971723. 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 FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)?

FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM) is a medical device that received FDA 510(k) clearance on 1997-07-30. The listed applicant is Arthrex, Inc.. The 510(k) number is K971723.

When did FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM) receive FDA 510(k) clearance?

FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM) received FDA 510(k) clearance on 1997-07-30, under 510(k) number K971723.

Who is the listed applicant for FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)?

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 (11.7MM)/(7.5MM)?

The FDA product code for FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM) 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.

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: 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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