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FDA 510(k)

ACUFEX ROTATOR CUFF FIXATION BUTTON

K-Number: K941740 · 1995-06-30

ApplicantAcufex Microsurgical, Inc.
Decision Date1995-06-30
Product CodeKGS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACUFEX ROTATOR CUFF FIXATION BUTTON is the device name listed in this FDA 510(k) record. The listed applicant is Acufex Microsurgical, Inc.. It received FDA 510(k) clearance on 1995-06-30 under 510(k) number K941740. The device is classified under product code KGS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUFEX ROTATOR CUFF FIXATION BUTTON?

ACUFEX ROTATOR CUFF FIXATION BUTTON is a medical device that received FDA 510(k) clearance on 1995-06-30. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K941740.

When did ACUFEX ROTATOR CUFF FIXATION BUTTON receive FDA 510(k) clearance?

ACUFEX ROTATOR CUFF FIXATION BUTTON received FDA 510(k) clearance on 1995-06-30, under 510(k) number K941740.

Who is the listed applicant for ACUFEX ROTATOR CUFF FIXATION BUTTON?

The FDA 510(k) record lists Acufex Microsurgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUFEX ROTATOR CUFF FIXATION BUTTON?

The FDA product code for ACUFEX ROTATOR CUFF FIXATION BUTTON is KGS.

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Other records listing Acufex Microsurgical, 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.

K961555ACUFEX TAG BIOABSORBABLE ANCHORSK961853PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSERK954246ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREWK952535ACUFEX ENDOBUTTON TAPEK953276ACUFEX TAG DELIVERY SYSTEMK953459ACUFEX TAG ANCHOR

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Related Devices (Code: KGS)

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.

K030031SOFT TISSUE ANCHORING WASHERSAccu-Speed, IncorporatedK020480RBMSmith & Nephew, Inc.K964935SUTURE LOCKSmith & Nephew Endoscopy, Inc.K930675MITEK CONE WASHERMitek Surgical Products, Inc.K904435VENTROFIL TENSION RELIEF SUTURE SETAesculap, Inc.K911225TRAY DOUGHThe Hygenic Corp.

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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