Company ยท US
Theken Spine, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2012. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 6 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 |
| MQP | Spinal Vertebral Body Replacement Device | 3 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 3 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 |
| MNI | Orthosis, Spinal Pedicle Fixation | 2 |
| MQV | Filler, Bone Void, Calcium Compound | 2 |
| HRX | Arthroscope | 1 |
| KNW | Instrument, Biopsy | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 |
| NOX | Filler, Bone Void, Synthetic Peptide | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 2012 | K121482 | INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY Theken Spine, LLC | HRX |
| Jun 27, 2012 | K121211 | VU APOD INTERVERTEBRAL BODY FUSION DEVICE Theken Spine, LLC | OVD |
| May 30, 2012 | K120829 | STAINLESS STEEL SPINAL SYSTEM Theken Spine, LLC | NKB |
| Feb 3, 2012 | K120047 | CORAL SPINAL SYSTEM Theken Spine, LLC | NKB |
| Aug 2, 2011 | K111675 | VU C*POD INTERVERTEBRAL BODY FUSION DEVICE Theken Spine, LLC | ODP |
| Jan 5, 2011 | K103228 | PARAMOUNT R IBF DEVICE Theken Spine, LLC | MAX |
| Dec 16, 2010 | K102323 | CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE Theken Spine, LLC | OVE |
| Sep 2, 2010 | K101310 | VU APOD INTERVERTEBRAL BODY FUSION DEVICE Theken Spine, LLC | OVD |
| Aug 12, 2010 | K100970 | STAINLESS STEEL SPINAL SYSTEM Theken Spine, LLC | NKB |
| Jun 10, 2009 | K091266 | THEKEN CORAL SPINAL SYSTEM Theken Spine, LLC | NKB |
| Mar 27, 2009 | K083863 | THEKEN ATOLL OCT SPINAL SYSTEM Theken Spine, LLC | MNI |
| Mar 13, 2009 | K083073 | THEKEN ATOLL CERVICO-THORACIC SYSTEM Theken Spine, LLC | MNI |
| Jan 2, 2009 | K082712 | THEKEN SPINE VU EPOD AND VU LPOD SYSTEM Theken Spine, LLC | MAX |
| Jul 2, 2008 | K080822 | VU APOD INTERVERTABRAL BODY FUSION DEVICE Theken Spine, LLC | OVD |
| Jun 17, 2008 | K081414 | MODIFICATION TO CORAL SPINAL SYSTEM Theken Spine, LLC | NKB |
| Apr 29, 2008 | K080790 | MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM Theken Spine, LLC | KWP |
| Apr 25, 2008 | K080690 | MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM Theken Spine, LLC | KWQ |
| Dec 21, 2007 | K072407 | BODYFORM THORACIC FIXATION SYSTEM Theken Spine, LLC | KWQ |
| Aug 22, 2007 | K070962 | CORAL PEDICLE SCREW SYSTEM Theken Spine, LLC | NKB |
| Jul 30, 2007 | K071031 | VU E*POD VERTEBRAL BODY REPLACEMENT Theken Spine, LLC | MQP |
| Jun 28, 2007 | K070786 | X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT Theken Spine, LLC | MQP |
| May 30, 2007 | K070638 | THEKEN ATOLL CERVICO-THORACIC SYSTEM Theken Spine, LLC | KWP |
| Apr 25, 2007 | K070381 | THEKEN VU MESH VBR SYSTEM Theken Spine, LLC | MQP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2010 | Theken Spine Llc Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered in a syringe which is packaged in an aluminum-backed polyethylene pouch and is distributed one (1) pouch per b Terminated |
NOX | K053228 |
| Oct 19, 2010 | Theken Spine Llc Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate Terminated |
KWQ | K080690 |
| Sep 3, 2009 | Theken Spine LLC iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04. Terminated |
MQV | K040134 |
| Nov 18, 2008 | Theken Spine LLC Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow Loc (Bone Marrow Specimen Acquisition System), 2. "J" Style Bone Marrow Biopsy Needle (11g (3.0mm)x10cm (4.0)) Terminated |
KNW | K993435 |
| Sep 18, 2008 | Theken Spine LLC FormPutty Bone Void Filler 10cc
The product is sealed in a foil pouch and then placed in a box following sterilization.
Part # 50-07-0100
Is a flowable resorbable porous bone void filler composed o Terminated |
MQV | K053228 |
| Nov 23, 2005 | Theken Spine LLC Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System). Terminated |
LXH | K041592 |