Medical Device Manufacturer · US , Akron , OH

Theken Spine, LLC - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 2007
23
Total
23
Cleared
0
Denied

Theken Spine, LLC has 23 FDA 510(k) cleared orthopedic devices. Based in Akron, US.

Historical record: 23 cleared submissions from 2007 to 2012.

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 - Theken Spine, LLC
23 devices
1-23 of 23
Cleared Aug 28, 2012
INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY
K121482 · HRX
Orthopedic · 102d
Cleared Jun 27, 2012
VU APOD INTERVERTEBRAL BODY FUSION DEVICE
K121211 · OVD
Orthopedic · 68d
Cleared May 30, 2012
STAINLESS STEEL SPINAL SYSTEM
K120829 · NKB
Orthopedic · 72d
Cleared Feb 03, 2012
CORAL SPINAL SYSTEM
K120047 · NKB
Orthopedic · 28d
Cleared Aug 02, 2011
VU C*POD INTERVERTEBRAL BODY FUSION DEVICE
K111675 · ODP
Orthopedic · 48d
Cleared Jan 05, 2011
PARAMOUNT R IBF DEVICE
K103228 · MAX
Orthopedic · 64d
Cleared Dec 16, 2010
CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE
K102323 · OVE
Orthopedic · 121d
Cleared Sep 02, 2010
VU APOD INTERVERTEBRAL BODY FUSION DEVICE
K101310 · OVD
Orthopedic · 114d
Cleared Aug 12, 2010
STAINLESS STEEL SPINAL SYSTEM
K100970 · NKB
Orthopedic · 126d
Cleared Jun 10, 2009
THEKEN CORAL SPINAL SYSTEM
K091266 · NKB
Orthopedic · 41d
Cleared Mar 27, 2009
THEKEN ATOLL OCT SPINAL SYSTEM
K083863 · MNI
Orthopedic · 88d
Cleared Mar 13, 2009
THEKEN ATOLL CERVICO-THORACIC SYSTEM
K083073 · MNI
Orthopedic · 149d
Cleared Jan 02, 2009
THEKEN SPINE VU EPOD AND VU LPOD SYSTEM
K082712 · MAX
Orthopedic · 108d
Cleared Jul 02, 2008
VU APOD INTERVERTABRAL BODY FUSION DEVICE
K080822 · OVD
Orthopedic · 100d
Cleared Jun 17, 2008
MODIFICATION TO CORAL SPINAL SYSTEM
K081414 · NKB
Orthopedic · 28d
Cleared Apr 29, 2008
MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM
K080790 · KWP
Orthopedic · 40d
Cleared Apr 25, 2008
MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM
K080690 · KWQ
Orthopedic · 45d
Cleared Dec 21, 2007
BODYFORM THORACIC FIXATION SYSTEM
K072407 · KWQ
Orthopedic · 116d
Cleared Aug 22, 2007
CORAL PEDICLE SCREW SYSTEM
K070962 · NKB
Orthopedic · 139d
Cleared Jul 30, 2007
VU E*POD VERTEBRAL BODY REPLACEMENT
K071031 · MQP
Orthopedic · 110d
Cleared Jun 28, 2007
X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT
K070786 · MQP
Orthopedic · 98d
Cleared May 30, 2007
THEKEN ATOLL CERVICO-THORACIC SYSTEM
K070638 · KWP
Orthopedic · 84d
Cleared Apr 25, 2007
THEKEN VU MESH VBR SYSTEM
K070381 · MQP
Orthopedic · 76d
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