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

Ortho Tec, LLC has 22 FDA 510(k) cleared orthopedic devices. Based in Pleasant Hill, US.

Historical record: 22 cleared submissions from 1999 to 2004.

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 - Ortho Tec, LLC
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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