Medical Device Manufacturer · US , Austin , TX

Spinal Concepts, Inc. - FDA 510(k) Cleared Devices

33 submissions · 28 cleared · Since 1997

33

Total

28

Cleared

0

Denied

FDA 510(k) Regulatory Record - Spinal Concepts, Inc. Orthopedic ✕

32 devices

1-12 of 32

Cleared May 19, 2005

FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE

Orthopedic · 29d

Cleared Jul 01, 2004

SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM

Orthopedic · 163d

Cleared May 27, 2004

SPINAL CONCEPTS INC. CODA

Orthopedic · 188d

Cleared Feb 18, 2004

SPINAL CONCEPTS INC. CADENCE AND TRAXIS

Orthopedic · 103d

Cleared Sep 17, 2003

SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM

Orthopedic · 93d

Cleared Sep 11, 2003

SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM

Orthopedic · 76d

Cleared Aug 22, 2003

TRAXIS CEMENT RESTRICTOR

Orthopedic · 119d

Cleared Aug 07, 2003

SPINAL CONCEPTS, INC. INFIX SYSTEM

Orthopedic · 69d

Cleared Jul 24, 2003

MODIFICATION TO FORTITUDE CEMENT RESTRICTOR

Orthopedic · 38d

Cleared Jul 17, 2003

SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM

Orthopedic · 189d

Cleared Jul 12, 2003

SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE

Orthopedic · 22d

Cleared Mar 28, 2003

SPINAL CONCEPTS INC. PATHFINDER

Orthopedic · 29d