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FDA 510(k)

ACUFEX INTERFERENCE SCREW AND SCREWDRIVER

K-Number: K883910 · 1988-10-12

ApplicantAcufex Microsurgical, Inc.
Decision Date1988-10-12
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUFEX INTERFERENCE SCREW AND SCREWDRIVER 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 1988-10-12 under 510(k) number K883910. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUFEX INTERFERENCE SCREW AND SCREWDRIVER?

ACUFEX INTERFERENCE SCREW AND SCREWDRIVER is a medical device that received FDA 510(k) clearance on 1988-10-12. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K883910.

When did ACUFEX INTERFERENCE SCREW AND SCREWDRIVER receive FDA 510(k) clearance?

ACUFEX INTERFERENCE SCREW AND SCREWDRIVER received FDA 510(k) clearance on 1988-10-12, under 510(k) number K883910.

Who is the listed applicant for ACUFEX INTERFERENCE SCREW AND SCREWDRIVER?

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 INTERFERENCE SCREW AND SCREWDRIVER?

The FDA product code for ACUFEX INTERFERENCE SCREW AND SCREWDRIVER is HWC. This falls under the Cardiovascular category.

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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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Official Source

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