Medical Device Manufacturer · US , Round Rock , TX

Scient'X USA, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2003

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Scient'X USA, Inc. Orthopedic ✕

4 devices

1-4 of 4

Cleared Jan 29, 2009

ANTERIOR BUTTRESS PLATE

Orthopedic · 241d

Cleared May 30, 2008

SCIENT'X TRIBECA VBR

Orthopedic · 88d

Cleared Jan 19, 2006

DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS

Orthopedic · 55d

Cleared May 13, 2003

MODIFICATION TO EASYS TRANSVERSE CONNECTION

Orthopedic · 20d