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
1-12 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
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