Medical Device Manufacturer · US , Center Valley , PA

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

22 submissions · 22 cleared · Since 2007
22
Total
22
Cleared
0
Denied
FDA 510(k) Regulatory Record - Aesculap Implant Systems, Inc. Orthopedic
21 devices
1-21 of 21
Cleared May 25, 2016
ArcadiusXP C Spinal System
K153629 · OVE
Orthopedic · 159d
Cleared Jan 22, 2014
AESCULAP PEEK XP SPINAL IMPLANT SYSTEM
K132421 · MAX
Orthopedic · 170d
Cleared Mar 12, 2013
S4 SPINAL SYSTEM
K123939 · NKB
Orthopedic · 82d
Cleared Dec 12, 2012
S4 SPINAL SYSTEM
K123352 · NKB
Orthopedic · 42d
Cleared Aug 04, 2011
AESCULAP SIBD XP SPINAL SYSTEM
K111122 · OVD
Orthopedic · 105d
Cleared Dec 02, 2010
LAMINOPLASY PLATING SYSTEM
K103284 · NQW
Orthopedic · 27d
Cleared Jul 20, 2010
AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM
K100802 · OVD
Orthopedic · 120d
Cleared Sep 22, 2009
EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM
K092143 · MEH
Orthopedic · 69d
Cleared Jul 02, 2009
MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM
K083004 · NKB
Orthopedic · 267d
Cleared Mar 04, 2009
AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM
K083311 · ODP
Orthopedic · 114d
Cleared Jan 15, 2009
MODIFICATION TO: METHA HIP SYSTEM
K083495 · LZO
Orthopedic · 51d
Cleared Nov 20, 2008
BIOLOX DELTA CERAMIC FEMORAL HEAD
K082991 · LZO
Orthopedic · 44d
Cleared Sep 22, 2008
UNIVATION UNICONDYLAR KNEE SYSTEM
K081293 · HRY
Orthopedic · 138d
Cleared Sep 09, 2008
METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD
K082146 · LWJ
Orthopedic · 41d
Cleared Sep 04, 2008
AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
K080992 · HRS
Orthopedic · 150d
Cleared Aug 07, 2008
METHA SHORT STEM HIP SYSTEM
K081973 · LZO
Orthopedic · 28d
Cleared Jun 02, 2008
METHA HIP SYSTEM
K071916 · MEH
Orthopedic · 327d
Cleared May 01, 2008
AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE,...
K071983 · MAX
Orthopedic · 287d
Cleared Sep 14, 2007
COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY
K071499 · JWH
Orthopedic · 106d
Cleared Aug 21, 2007
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE)
K070981 · JWH
Orthopedic · 137d
Cleared Jun 01, 2007
COLUMBUS TOTAL KNEE SYSTEM AS
K071220 · JWH
Orthopedic · 30d
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