Theken Spine, LLC - FDA 510(k) Cleared Devices
Recent clearances: INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY, VU APOD INTERVERTEBRAL BODY FUSION DEVICE, STAINLESS STEEL SPINAL SYSTEM
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Theken Spine, LLC Orthopedic ✕
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