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FDA 510(k)

Fixone All Suture Anchor

K-Number: K192709 · 2020-12-15

ApplicantAju Pharm Co., Ltd.
Decision Date2020-12-15
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fixone All Suture 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 2020-12-15 under 510(k) number K192709. 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 Fixone All Suture Anchor?

Fixone All Suture Anchor is a medical device that received FDA 510(k) clearance on 2020-12-15. The listed applicant is Aju Pharm Co., Ltd.. The 510(k) number is K192709.

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

Fixone All Suture Anchor received FDA 510(k) clearance on 2020-12-15, under 510(k) number K192709.

Who is the listed applicant for Fixone All Suture 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 All Suture Anchor?

The FDA product code for Fixone All Suture Anchor is MBI.

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 ScrewK192484Fixone Biocomposite Anchor

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Related Devices (Code: MBI)

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.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, 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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