Medical Device Manufacturer · US , Round Rock , TX

Medicrea International - FDA 510(k) Cleared Devices

17 submissions · 16 cleared · Since 2011
17
Total
16
Cleared
0
Denied

Medicrea International has 16 FDA 510(k) cleared orthopedic devices. Based in Round Rock, US.

Last cleared in 2022. Active since 2011.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Medicrea International

17 devices
1-17 of 17
Cleared Apr 19, 2022
Infinity™ OCT System and PASS OCT Spinal System
K220810 · NKG
Orthopedic · 29d
Cleared Apr 08, 2022
CD Horizon™ Spinal System and PASS LP™ Spinal System
K220724 · NKB
Orthopedic · 25d
Cleared Feb 08, 2018
UNiD Spine Analyzer
K180091 · LLZ
Radiology · 27d
Cleared May 24, 2017
UNiD Spine Analyzer
K170172 · LLZ
Radiology · 125d
Cleared Jan 29, 2016
PASS OCT Patient Specific Rods
K153169 · NKG
Orthopedic · 88d
Cleared Feb 10, 2015
PASS LP Spinal System
K150049 · MNI
Orthopedic · 29d
Cleared Nov 04, 2014
PASS LP SPINAL SYSTEM
K140738 · MNI
Orthopedic · 224d
Cleared Jul 24, 2014
C-JAWS CERVICAL COMPRESSIVE STAPLE
K133906 · PHQ
Orthopedic · 213d
Cleared Dec 06, 2013
LIGAPASS
K132395 · OWI
Orthopedic · 127d
Cleared Nov 08, 2013
PASS LP SPINAL SYSTEM
K132574 · OSH
Orthopedic · 84d
Cleared Oct 03, 2013
PASS LP SPINAL SYSTEM
K132575 · OSH
Orthopedic · 48d
Cleared Mar 21, 2013
PASS OCT SPINAL SYSTEM
K121979 · KWP
Orthopedic · 258d
Cleared Feb 05, 2013
PASS LP SPINAL SYSTEM
K123138 · OSH
Orthopedic · 123d
Cleared Jul 18, 2012
MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE
K121323 · KWQ
Orthopedic · 77d
Cleared Feb 01, 2012
PASS LP SPINAL
K112736 · JDQ
Orthopedic · 134d
Cleared Nov 21, 2011
PASS LP SPINAL SYSTEM
K112493 · MNI
Orthopedic · 84d
Cleared Sep 26, 2011
PASS LP SPINAL SYSTEM
K110497 · MNH
Orthopedic · 216d
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