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FDA 510(k)

Fixone Biocomposite Anchor

K-Number: K192484 · 2020-03-11

ApplicantAju Pharm Co., Ltd.
Decision Date2020-03-11
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fixone Biocomposite Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Aju Pharm Co., Ltd.. It received FDA 510(k) clearance on 2020-03-11 under 510(k) number K192484. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fixone Biocomposite Anchor?

Fixone Biocomposite Anchor is a medical device that received FDA 510(k) clearance on 2020-03-11. The listed applicant is Aju Pharm Co., Ltd.. The 510(k) number is K192484.

When did Fixone Biocomposite Anchor receive FDA 510(k) clearance?

Fixone Biocomposite Anchor received FDA 510(k) clearance on 2020-03-11, under 510(k) number K192484.

Who is the listed applicant for Fixone Biocomposite Anchor?

The FDA 510(k) record lists Aju Pharm Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fixone Biocomposite Anchor?

The FDA product code for Fixone Biocomposite Anchor is MAI.

Other records listing Aju Pharm Co., Ltd. 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.

K233601Fixone Meniscal RepairK230892Fixone Biocomposite AnchorK222423Fixone All Suture AnchorK203523Fixone hybrid knotless anchorK193497Fixone Biocomposite Interference ScrewK192709Fixone All Suture Anchor

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Related Devices (Code: MAI)

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.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbHK254055OSSIOfiber® Suture AnchorOSSIO , Ltd.K251680Biosteon® ScrewBiocomposites, Ltd.K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation

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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