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

1-12 of 22

Cleared May 03, 2004

EOVIA CALCIUM PHOSPHATE CERAMIC

Orthopedic · 66d

Cleared Mar 12, 2004

MODIFICATION TO ORIA TOP CLIP SYSTEM

Orthopedic · 29d

Cleared Nov 20, 2003

ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS

Orthopedic · 238d

Cleared Oct 10, 2003

ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01

Orthopedic · 154d

Cleared Aug 20, 2003

MODIFICATION ORIA SPINAL SYSTEM

Orthopedic · 272d

Cleared Jun 27, 2003

Orthopedic · 262d

Cleared Jun 18, 2003

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

Orthopedic · 42d

Cleared Mar 20, 2003

Orthopedic · 29d

Cleared Mar 04, 2003

ORIA CERVICAL PLATES

Orthopedic · 147d

Cleared Feb 21, 2003

ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)

Orthopedic · 28d

Cleared Feb 21, 2003

ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06

Orthopedic · 28d

Cleared Feb 05, 2003

ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ

Orthopedic · 64d