K251555

Ultra™ Compression Screw System

510(k) number
K251555
Device name
Ultra™ Compression Screw System
Applicant
Pace Surgical PA · US
Product code
HWC — Screw, Fixation, Bone
Decision date
2025-11-06
Date received
2025-05-21
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain

Also available from FDA: K251555.pdf

Official FDA record: K251555
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.