Medical Device Manufacturer · US , Pleasant Hill , CA

Ortho Tec, LLC - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 1999
22
Total
22
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ortho Tec, LLC Orthopedic
22 devices
1-22 of 22
Cleared May 03, 2004
EOVIA CALCIUM PHOSPHATE CERAMIC
K040514 · MQV
Orthopedic · 66d
Cleared Mar 12, 2004
MODIFICATION TO ORIA TOP CLIP SYSTEM
K040346 · MNI
Orthopedic · 29d
Cleared Nov 20, 2003
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
K030958 · MNI
Orthopedic · 238d
Cleared Oct 10, 2003
ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01
K031471 · KWP
Orthopedic · 154d
Cleared Aug 20, 2003
MODIFICATION ORIA SPINAL SYSTEM
K023884 · KWP
Orthopedic · 272d
Cleared Jun 27, 2003
ORIA CLARIS
K023378 · MNH
Orthopedic · 262d
Cleared Jun 18, 2003
ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03
K031452 · KWP
Orthopedic · 42d
Cleared Mar 20, 2003
ORIA ZENITH
K030500 · KWQ
Orthopedic · 29d
Cleared Mar 04, 2003
ORIA CERVICAL PLATES
K023377 · KWQ
Orthopedic · 147d
Cleared Feb 21, 2003
ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)
K030252 · KWP
Orthopedic · 28d
Cleared Feb 21, 2003
ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
K030253 · KWP
Orthopedic · 28d
Cleared Feb 05, 2003
ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ
K023994 · MNH
Orthopedic · 64d
Cleared Nov 19, 2002
ORIA SPINAL CLIP SYSTEM
K021679 · KWP
Orthopedic · 182d
Cleared Jul 03, 2002
SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05,...
K021919 · KWP
Orthopedic · 22d
Cleared May 31, 2002
SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
K021379 · MNI
Orthopedic · 30d
Cleared Aug 07, 2001
SCS CLARIS SPINAL SCREWS, TYPES V,G,E
K011807 · MNI
Orthopedic · 57d
Cleared Jul 11, 2001
SCS DT-02 TRANSVERSE CONNECTOR
K003823 · KWP
Orthopedic · 212d
Cleared May 29, 2001
SCS CLOSED SCREW
K003733 · MNH
Orthopedic · 176d
Cleared May 08, 2001
CLARIS PLATE SYSTEM
K010369 · MNH
Orthopedic · 90d
Cleared Mar 20, 2001
ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION
K001535 · KWP
Orthopedic · 307d
Cleared Apr 10, 2000
5.0MM SPINAL SCREWS
K994288 · MNH
Orthopedic · 112d
Cleared Dec 17, 1999
OMNIAXIAL CONNECTOR
K993926 · MNH
Orthopedic · 29d
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