Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Fixone hybrid knotless anchor

K-Number: K203523 · 2021-12-25

ApplicantAju Pharm Co., Ltd.
Decision Date2021-12-25
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fixone hybrid knotless 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 2021-12-25 under 510(k) number K203523. 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 hybrid knotless anchor?

Fixone hybrid knotless anchor is a medical device that received FDA 510(k) clearance on 2021-12-25. The listed applicant is Aju Pharm Co., Ltd.. The 510(k) number is K203523.

When did Fixone hybrid knotless anchor receive FDA 510(k) clearance?

Fixone hybrid knotless anchor received FDA 510(k) clearance on 2021-12-25, under 510(k) number K203523.

Who is the listed applicant for Fixone hybrid knotless 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 hybrid knotless anchor?

The FDA product code for Fixone hybrid knotless 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 AnchorK193497Fixone Biocomposite Interference ScrewK192709Fixone All Suture AnchorK192484Fixone Biocomposite Anchor

View all 10 devices →

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.

↑