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FDA 510(k)

Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)

K-Number: K210122 · 2021-08-27

ApplicantOsteonic Co., Ltd.
Decision Date2021-08-27
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) is a medical device manufactured by Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2021-08-27 under approval number K210122. 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 Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)?

Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) is a medical device that received FDA 510(k) clearance on 2021-08-27. It is manufactured by Osteonic Co., Ltd.. The 510(k) number is K210122.

When was Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) approved by the FDA?

Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) received FDA 510(k) clearance on 2021-08-27, under approval number K210122.

What company makes Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)?

Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) is manufactured by Osteonic Co., Ltd..

What is the FDA product code for Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)?

The FDA product code for Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) is MAI.

Other Devices by Osteonic Co., Ltd.

K160363OPTIMUS CMF SYSTEM K190811Optimus NEURO System - Sterile Kit K183352Optimus Neuro System K202883Sterile bone screw (PEEK ACL screw) K211992Ortho MI System K202806Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)

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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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