Medical Device Manufacturer · US , Center Valley , PA

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

22 submissions · 22 cleared · Since 2010
22
Total
22
Cleared
0
Denied

FDA 510(k) cleared devices by Aesculap Implant Systems, LLC Orthopedic

22 devices
1-22 of 22
Cleared Jul 01, 2022
Ennovate Cervical Spinal and Occiput System
K213871 · NKG
Orthopedic · 200d
Cleared Jul 19, 2021
ENNOVATE Spinal System
K210963 · NKB
Orthopedic · 110d
Cleared Apr 26, 2018
ENNOVATE®
K180433 · NKB
Orthopedic · 65d
Cleared Dec 14, 2016
ENNOVATE Spinal System
K162134 · NKB
Orthopedic · 135d
Cleared Jul 08, 2016
Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments
K153700 · OLO
Orthopedic · 198d
Cleared May 16, 2016
Aesculap OrthoPilot Next Generation
K153396 · OLO
Orthopedic · 174d
Cleared Oct 21, 2015
S4 Cervical Spinal and Occiput Systems
K151938 · NKG
Orthopedic · 99d
Cleared Aug 13, 2015
Aesculap T-Space PEEK and XP Spinal System
K151056 · MAX
Orthopedic · 115d
Cleared May 29, 2015
Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System
K150544 · JWH
Orthopedic · 87d
Cleared Feb 24, 2015
AESCULAP ORTHOPILOT NEXT GENERATION
K141694 · OLO
Orthopedic · 245d
Cleared Feb 09, 2015
Excia Total Hip System
K150062 · LZO
Orthopedic · 27d
Cleared Nov 21, 2014
VEGA Knee System
K143106 · JWH
Orthopedic · 23d
Cleared Jul 21, 2014
EXCIA TOTAL HIP SYSTEM
K140915 · LZO
Orthopedic · 102d
Cleared Oct 17, 2013
UNIVATION
K131167 · HRY
Orthopedic · 176d
Cleared Dec 17, 2012
COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM
K120955 · JWH
Orthopedic · 262d
Cleared Sep 11, 2012
QUINTEX CERVICAL PLATING SYSTEM
K121801 · KWQ
Orthopedic · 84d
Cleared Mar 19, 2012
METHA HIP SYSTEM
K112682 · LZO
Orthopedic · 186d
Cleared Jun 15, 2011
BIOSPINE VBR SYSTEM
K110864 · MQP
Orthopedic · 78d
Cleared Dec 21, 2010
TARGON FN SYSTEM
K102057 · KTT
Orthopedic · 152d
Cleared Dec 09, 2010
PREVISION HIP SYSTEM WITH RECON RING
K102424 · MEH
Orthopedic · 106d
Cleared Nov 24, 2010
HTO PLATING SYSTEM
K102505 · HRS
Orthopedic · 84d
Cleared Sep 02, 2010
QUINTEX CERVICAL PLATING SYSTEM
K100243 · KWQ
Orthopedic · 218d
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