Medical Device Manufacturer · US , Center Valley , PA

Aesculap Implant Systems, LLC - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 2010

Recent clearances: Ennovate Cervical Spinal and Occiput System, ENNOVATE Spinal System, ENNOVATE®

22

Total

22

Cleared

0

Denied

FDA 510(k) Regulatory Record - Aesculap Implant Systems, LLC Orthopedic ✕

22 devices

1-12 of 22

Cleared Jul 01, 2022

Ennovate Cervical Spinal and Occiput System

Orthopedic · 200d

Cleared Jul 19, 2021

ENNOVATE Spinal System

Orthopedic · 110d

Cleared Apr 26, 2018

Orthopedic · 65d

Cleared Dec 14, 2016

ENNOVATE Spinal System

Orthopedic · 135d

Cleared Jul 08, 2016

Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments

Orthopedic · 198d

Cleared May 16, 2016

Aesculap OrthoPilot Next Generation

Orthopedic · 174d

Cleared Oct 21, 2015

S4 Cervical Spinal and Occiput Systems

Orthopedic · 99d

Cleared Aug 13, 2015

Aesculap T-Space PEEK and XP Spinal System

Orthopedic · 115d

Cleared May 29, 2015

Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System

Orthopedic · 87d

Cleared Feb 24, 2015

AESCULAP ORTHOPILOT NEXT GENERATION

Orthopedic · 245d

Cleared Feb 09, 2015

Excia Total Hip System

Orthopedic · 27d

Cleared Nov 21, 2014

VEGA Knee System

Orthopedic · 23d