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FDA 510(k)

ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001

K-Number: K981187 · 1998-07-01

ApplicantArthrex, Inc.
Decision Date1998-07-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001 is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 1998-07-01 under 510(k) number K981187. 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 ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001?

ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001 is a medical device that received FDA 510(k) clearance on 1998-07-01. The listed applicant is Arthrex, Inc.. The 510(k) number is K981187.

When did ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001 receive FDA 510(k) clearance?

ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001 received FDA 510(k) clearance on 1998-07-01, under 510(k) number K981187.

Who is the listed applicant for ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001?

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

What is the FDA product code for ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001?

The FDA product code for ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001 is HWC. This falls under the Cardiovascular category.

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Other records listing Arthrex, Inc. as applicant

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Related Devices (Code: HWC)

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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