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

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
1-12 of 33
Cleared May 19, 2005
FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE
K051000 · MQP
Orthopedic · 29d
Cleared Apr 15, 2005
HARMONY PORT SYSTEM, MODEL 1907 SERIES
K050706 · GZT
Neurology · 28d
Cleared Jul 01, 2004
SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM
K040096 · KWP
Orthopedic · 163d
Cleared May 27, 2004
SPINAL CONCEPTS INC. CODA
K033663 · MQP
Orthopedic · 188d
Cleared Feb 18, 2004
SPINAL CONCEPTS INC. CADENCE AND TRAXIS
K033517 · MQP
Orthopedic · 103d
Cleared Sep 17, 2003
SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM
K031855 · KWQ
Orthopedic · 93d
Cleared Sep 11, 2003
SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM
K031985 · MNI
Orthopedic · 76d
Cleared Aug 22, 2003
TRAXIS CEMENT RESTRICTOR
K031318 · JDK
Orthopedic · 119d
Cleared Aug 07, 2003
SPINAL CONCEPTS, INC. INFIX SYSTEM
K031672 · MQP
Orthopedic · 69d
Cleared Jul 24, 2003
MODIFICATION TO FORTITUDE CEMENT RESTRICTOR
K031837 · JDK
Orthopedic · 38d
Cleared Jul 17, 2003
SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM
K030087 · NKB
Orthopedic · 189d
Cleared Jul 12, 2003
SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE
K031914 · MQP
Orthopedic · 22d
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