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510(k) K233567

OsteoCoil™ Nitinol Compression System (Multiple Component PNs) by Flower Orthopedics Corporation Dba Conventus Flower Ortho — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2024
Date Received
November 6, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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