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FDA 510(k)

ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE

K-Number: K896310 · 1989-11-20

ApplicantAcufex Microsurgical, Inc.
Decision Date1989-11-20
Product CodeKGS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE 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 1989-11-20 under 510(k) number K896310. 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 FIXATION BUTTON; RETENTION BAR, WEDGE?

ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE is a medical device that received FDA 510(k) clearance on 1989-11-20. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K896310.

When did ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE receive FDA 510(k) clearance?

ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE received FDA 510(k) clearance on 1989-11-20, under 510(k) number K896310.

Who is the listed applicant for ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE?

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 FIXATION BUTTON; RETENTION BAR, WEDGE?

The FDA product code for ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE is KGS.

Related Clinical Trials

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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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.K941740ACUFEX ROTATOR CUFF FIXATION BUTTONAcufex Microsurgical, Inc.K930675MITEK CONE WASHERMitek Surgical Products, Inc.K904435VENTROFIL TENSION RELIEF SUTURE SETAesculap, Inc.

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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