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FDA 510(k)

Sterile bone screw (PEEK ACL screw)

K-Number: K202883 · 2020-11-25

ApplicantOsteonic Co., Ltd.
Decision Date2020-11-25
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sterile bone screw (PEEK ACL screw) is a medical device manufactured by Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2020-11-25 under approval number K202883. 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 Sterile bone screw (PEEK ACL screw)?

Sterile bone screw (PEEK ACL screw) is a medical device that received FDA 510(k) clearance on 2020-11-25. It is manufactured by Osteonic Co., Ltd.. The 510(k) number is K202883.

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

Sterile bone screw (PEEK ACL screw) received FDA 510(k) clearance on 2020-11-25, under approval number K202883.

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

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

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

The FDA product code for Sterile bone screw (PEEK ACL screw) is MBI.

Other Devices by Osteonic Co., Ltd.

K160363OPTIMUS CMF SYSTEM K190811Optimus NEURO System - Sterile Kit K183352Optimus Neuro System K211992Ortho MI System K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) 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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