Medical Device Manufacturer · US , Raynham , MA

Depuy Synthes, Inc. - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2015

Recent clearances: SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System

View 1 510(k) Devices ↓

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Depuy Synthes, Inc. Orthopedic ✕

1 devices

1-1 of 1

Cleared Sep 03, 2015

SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System

Orthopedic · 56d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 22, 2026