Medical Device Manufacturer · US , Pleasant Hill , CA

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

22 submissions · 22 cleared · Since 1999

Total

Cleared

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

1-12 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

ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03

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

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

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