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FDA 510(k)

ARTHREX SUTURE ANCHOR SCREW SYSTEM

K-Number: K934327 · 1995-09-15

ApplicantArthrex, Inc.
Decision Date1995-09-15
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHREX SUTURE ANCHOR SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 1995-09-15 under 510(k) number K934327. 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 ARTHREX SUTURE ANCHOR SCREW SYSTEM?

ARTHREX SUTURE ANCHOR SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1995-09-15. The listed applicant is Arthrex, Inc.. The 510(k) number is K934327.

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

ARTHREX SUTURE ANCHOR SCREW SYSTEM received FDA 510(k) clearance on 1995-09-15, under 510(k) number K934327.

Who is the listed applicant for ARTHREX SUTURE ANCHOR SCREW SYSTEM?

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 ARTHREX SUTURE ANCHOR SCREW SYSTEM?

The FDA product code for ARTHREX SUTURE ANCHOR SCREW SYSTEM 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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