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FDA 510(k)

WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE

K-Number: K981967 · 1998-07-17

ApplicantArthrotek/Biomet, Inc.
Decision Date1998-07-17
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE is the device name listed in this FDA 510(k) record. The listed applicant is Arthrotek/Biomet, Inc.. It received FDA 510(k) clearance on 1998-07-17 under 510(k) number K981967. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE?

WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE is a medical device that received FDA 510(k) clearance on 1998-07-17. The listed applicant is Arthrotek/Biomet, Inc.. The 510(k) number is K981967.

When did WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE receive FDA 510(k) clearance?

WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE received FDA 510(k) clearance on 1998-07-17, under 510(k) number K981967.

Who is the listed applicant for WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE?

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

What is the FDA product code for WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE?

The FDA product code for WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE is MBI.

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Related Devices (Code: MBI)

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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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