FDA 510(k) Premarket Notification K243467: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)

Submission Details & Decision

Normalized public record details for 510(k) notification K243467.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K243467

Applicant / Sponsor

Osteonic Co., Ltd.

Device Name

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)

Product Code

MAI

Decision Date

2024-12-03

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Orthopedic (OR)

Clearance Type

Special

Third Party Flag

Date Received

2024-11-08

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