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FDA 510(k)

Fix2Lock(PEEK Self Punching)

K-Number: K231322 · 2023-06-07

ApplicantOsteonic Co., Ltd.
Decision Date2023-06-07
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fix2Lock(PEEK Self Punching) is the device name listed in this FDA 510(k) record. The listed applicant is Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2023-06-07 under 510(k) number K231322. 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 Fix2Lock(PEEK Self Punching)?

Fix2Lock(PEEK Self Punching) is a medical device that received FDA 510(k) clearance on 2023-06-07. The listed applicant is Osteonic Co., Ltd.. The 510(k) number is K231322.

When did Fix2Lock(PEEK Self Punching) receive FDA 510(k) clearance?

Fix2Lock(PEEK Self Punching) received FDA 510(k) clearance on 2023-06-07, under 510(k) number K231322.

Who is the listed applicant for Fix2Lock(PEEK Self Punching)?

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

What is the FDA product code for Fix2Lock(PEEK Self Punching)?

The FDA product code for Fix2Lock(PEEK Self Punching) is MBI.

Other records listing Osteonic 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.

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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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