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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 the device name listed in this FDA 510(k) record. The listed applicant is Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2021-08-27 under 510(k) 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. The listed applicant is Osteonic Co., Ltd.. The 510(k) number is K210122.

When did Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) receive FDA 510(k) clearance?

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

Who is the listed applicant for Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)?

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 Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)?

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

Related Clinical Trials

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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Other records listing Osteonic Co., Ltd. as applicant

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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.

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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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