Medical Device Manufacturer · US , Round Rock , TX

Medicrea Technologies - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2007
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medicrea Technologies Orthopedic ✕
14 devices
1-12 of 14
Cleared Aug 23, 2011
PASS ANTERIOR SPINAL SYSTEM
K102406 · KWQ
Orthopedic · 364d
Cleared Jul 22, 2010
IMPIX LUMBAR INTERBODY DEVICE
K100544 · MAX
Orthopedic · 147d
Cleared May 19, 2010
IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF
K083798 · MAX
Orthopedic · 513d
Cleared Mar 04, 2010
PASS LP SPINAL SYSTEM
K100297 · MNI
Orthopedic · 30d
Cleared Jul 31, 2009
PASS LP SPINAL SYSTEM
K083810 · MNI
Orthopedic · 221d
Cleared Dec 10, 2008
PASS LP SPINAL SYSTEM
K083308 · MNI
Orthopedic · 30d
Cleared Oct 03, 2008
PASS 2 SPINAL SYSTEM
K082069 · MNI
Orthopedic · 73d
Cleared Oct 03, 2008
PASS LP SPINAL SYSTEM
K082577 · MNH
Orthopedic · 28d
Cleared Apr 09, 2008
PASS SPINAL SYSTEM
K080099 · MNI
Orthopedic · 86d
Cleared Dec 10, 2007
IMPIX SPACER
K072226 · MAX
Orthopedic · 122d
Cleared Oct 18, 2007
MODIFICATION TO PASSMED SPINAL SYSTEM
K070530 · MNH
Orthopedic · 237d
Cleared Sep 21, 2007
MODIFICATION TO PASSMED SPINAL SYSTEM
K070276 · MNI
Orthopedic · 235d
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