Medical Device Manufacturer · US , West Chester , PA

Synthes USA Products, LLC - FDA 510(k) Cleared Devices

61 submissions · 61 cleared · Since 2010

Recent clearances: MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System, SyntheCel Dura Repair, MAXFRAME Multi-Axial Correction System (aka MAXFRAME)

61
Total
61
Cleared
0
Denied

Synthes USA Products, LLC has 61 FDA 510(k) cleared orthopedic devices. Based in West Chester, US.

Latest FDA clearance: Jun 2026. Active since 2010.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Synthes (USA) Products, LLC as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Synthes USA Products, LLC

61 devices
1-12 of 61

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