FDA 510(k) Applications Submitted by Aesculap Implant Systems, LLC

FDA 510(k) Number Submission Date Device Name Applicant
K141694 06/24/2014 AESCULAP ORTHOPILOT NEXT GENERATION AESCULAP IMPLANT SYSTEMS, LLC
K140915 04/10/2014 EXCIA TOTAL HIP SYSTEM AESCULAP IMPLANT SYSTEMS, LLC
K131167 04/24/2013 UNIVATION AESCULAP IMPLANT SYSTEMS, LLC
K150062 01/13/2015 Excia Total Hip System AESCULAP IMPLANT SYSTEMS, LLC
K150544 03/03/2015 Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System AESCULAP IMPLANT SYSTEMS, LLC
K143106 10/29/2014 VEGA Knee System AESCULAP IMPLANT SYSTEMS, LLC
K120955 03/30/2012 COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM AESCULAP IMPLANT SYSTEMS, LLC
K102057 07/22/2010 TARGON FN SYSTEM AESCULAP IMPLANT SYSTEMS, LLC
K102424 08/25/2010 PREVISION HIP SYSTEM WITH RECON RING AESCULAP IMPLANT SYSTEMS, LLC
K102505 09/01/2010 HTO PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, LLC
K112682 09/15/2011 METHA HIP SYSTEM AESCULAP IMPLANT SYSTEMS, LLC
K100243 01/27/2010 QUINTEX CERVICAL PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, LLC
K110864 03/29/2011 BIOSPINE VBR SYSTEM AESCULAP IMPLANT SYSTEMS, LLC
K121801 06/19/2012 QUINTEX CERVICAL PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, LLC
K151938 07/14/2015 S4 Cervical Spinal and Occiput Systems AESCULAP IMPLANT SYSTEMS, LLC
K151056 04/20/2015 Aesculap T-Space PEEK and XP Spinal System AESCULAP IMPLANT SYSTEMS, LLC
K180433 02/20/2018 ENNOVATE« Aesculap Implant Systems, LLC
K210963 03/31/2021 ENNOVATE Spinal System Aesculap Implant Systems, LLC
K162134 08/01/2016 ENNOVATE Spinal System Aesculap Implant Systems, LLC
K153396 11/24/2015 Aesculap OrthoPilot Next Generation AESCULAP IMPLANT SYSTEMS, LLC
K153700 12/23/2015 Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments AESCULAP IMPLANT SYSTEMS, LLC


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