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510(k) K251555

Ultra™ Compression Screw System by Pace Surgical — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2025
Date Received
May 21, 2025
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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