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FDA 510(k)

ACUFLEX LEVY ACL DRILL GUIDE SYS

K-Number: K832277 · 1983-08-16

ApplicantAcufex Microsurgical, Inc.
Decision Date1983-08-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUFLEX LEVY ACL DRILL GUIDE SYS 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 1983-08-16 under 510(k) number K832277. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUFLEX LEVY ACL DRILL GUIDE SYS?

ACUFLEX LEVY ACL DRILL GUIDE SYS is a medical device that received FDA 510(k) clearance on 1983-08-16. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K832277.

When did ACUFLEX LEVY ACL DRILL GUIDE SYS receive FDA 510(k) clearance?

ACUFLEX LEVY ACL DRILL GUIDE SYS received FDA 510(k) clearance on 1983-08-16, under 510(k) number K832277.

Who is the listed applicant for ACUFLEX LEVY ACL DRILL GUIDE SYS?

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 ACUFLEX LEVY ACL DRILL GUIDE SYS?

The FDA product code for ACUFLEX LEVY ACL DRILL GUIDE SYS is HRX.

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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.

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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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