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FDA 510(k)

CRUCIATE LIGAMENT BUTTON

K-Number: K813581 · 1982-03-23

ApplicantBiomet, Inc.
Decision Date1982-03-23
Product CodeKGS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRUCIATE LIGAMENT BUTTON is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1982-03-23 under 510(k) number K813581. The device is classified under product code KGS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRUCIATE LIGAMENT BUTTON?

CRUCIATE LIGAMENT BUTTON is a medical device that received FDA 510(k) clearance on 1982-03-23. The listed applicant is Biomet, Inc.. The 510(k) number is K813581.

When did CRUCIATE LIGAMENT BUTTON receive FDA 510(k) clearance?

CRUCIATE LIGAMENT BUTTON received FDA 510(k) clearance on 1982-03-23, under 510(k) number K813581.

Who is the listed applicant for CRUCIATE LIGAMENT BUTTON?

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

What is the FDA product code for CRUCIATE LIGAMENT BUTTON?

The FDA product code for CRUCIATE LIGAMENT BUTTON is KGS.

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Other records listing Biomet, Inc. as applicant

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Related Devices (Code: KGS)

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.

K030031SOFT TISSUE ANCHORING WASHERSAccu-Speed, IncorporatedK020480RBMSmith & Nephew, Inc.K964935SUTURE LOCKSmith & Nephew Endoscopy, Inc.K941740ACUFEX ROTATOR CUFF FIXATION BUTTONAcufex Microsurgical, Inc.K930675MITEK CONE WASHERMitek Surgical Products, Inc.K904435VENTROFIL TENSION RELIEF SUTURE SETAesculap, Inc.

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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