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FDA 510(k)

INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR

K-Number: K921481 · 1993-08-24

ApplicantAcufex Microsurgical, Inc.
Decision Date1993-08-24
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR 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 1993-08-24 under 510(k) number K921481. 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 INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR?

INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR is a medical device that received FDA 510(k) clearance on 1993-08-24. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K921481.

When did INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR receive FDA 510(k) clearance?

INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR received FDA 510(k) clearance on 1993-08-24, under 510(k) number K921481.

Who is the listed applicant for INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR?

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 INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR?

The FDA product code for INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR is HWC. This falls under the Cardiovascular category.

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Other records listing Acufex Microsurgical, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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