Theken Spine, LLC - FDA 510(k) Cleared Devices
23
Total
23
Cleared
0
Denied
23 devices
Cleared
Aug 28, 2012
INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY
Orthopedic
102d
Cleared
Jun 27, 2012
VU APOD INTERVERTEBRAL BODY FUSION DEVICE
Orthopedic
68d
Cleared
May 30, 2012
STAINLESS STEEL SPINAL SYSTEM
Orthopedic
72d
Cleared
Feb 03, 2012
CORAL SPINAL SYSTEM
Orthopedic
28d
Cleared
Aug 02, 2011
VU C*POD INTERVERTEBRAL BODY FUSION DEVICE
Orthopedic
48d
Cleared
Jan 05, 2011
PARAMOUNT R IBF DEVICE
Orthopedic
64d
Cleared
Dec 16, 2010
CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE
Orthopedic
121d
Cleared
Sep 02, 2010
VU APOD INTERVERTEBRAL BODY FUSION DEVICE
Orthopedic
114d
Cleared
Aug 12, 2010
STAINLESS STEEL SPINAL SYSTEM
Orthopedic
126d
Cleared
Jun 10, 2009
THEKEN CORAL SPINAL SYSTEM
Orthopedic
41d
Cleared
Mar 27, 2009
THEKEN ATOLL OCT SPINAL SYSTEM
Orthopedic
88d
Cleared
Mar 13, 2009
THEKEN ATOLL CERVICO-THORACIC SYSTEM
Orthopedic
149d
Cleared
Jan 02, 2009
THEKEN SPINE VU EPOD AND VU LPOD SYSTEM
Orthopedic
108d
Cleared
Jul 02, 2008
VU APOD INTERVERTABRAL BODY FUSION DEVICE
Orthopedic
100d
Cleared
Jun 17, 2008
MODIFICATION TO CORAL SPINAL SYSTEM
Orthopedic
28d
Cleared
Apr 29, 2008
MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM
Orthopedic
40d
Cleared
Apr 25, 2008
MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM
Orthopedic
45d
Cleared
Dec 21, 2007
BODYFORM THORACIC FIXATION SYSTEM
Orthopedic
116d
Cleared
Aug 22, 2007
CORAL PEDICLE SCREW SYSTEM
Orthopedic
139d
Cleared
Jul 30, 2007
VU E*POD VERTEBRAL BODY REPLACEMENT
Orthopedic
110d
Cleared
Jun 28, 2007
X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT
Orthopedic
98d
Cleared
May 30, 2007
THEKEN ATOLL CERVICO-THORACIC SYSTEM
Orthopedic
84d
Cleared
Apr 25, 2007
THEKEN VU MESH VBR SYSTEM
Orthopedic
76d