Spinal Concepts, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Spinal Concepts, Inc. - FDA 510(k) Cleared Devices
Recent clearances: FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE, HARMONY PORT SYSTEM, MODEL 1907 SERIES, SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM
33
Total
28
Cleared
0
Denied
Spinal Concepts, Inc. has 28 FDA 510(k) cleared orthopedic devices. Based in Austin, US.
Historical record: 28 cleared submissions from 1997 to 2005.
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 - Spinal Concepts, Inc.
33 devices
Cleared
May 19, 2005
FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE
Orthopedic
29d
Cleared
Apr 15, 2005
HARMONY PORT SYSTEM, MODEL 1907 SERIES
Neurology
28d
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