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510(k) K230397

Cut Screw - Percutaneous Compression Screw by GM Dos Reis Industria e Comercio Ltda. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2023
Date Received
February 14, 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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