Company ยท US
Paradigm Spine, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2022. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NQP | Posterior Metal/Polymer Spinal System, Fusion | 5 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 |
| PEK | Spinous Process Plate | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 27, 2022 | K213493 | Fortilink with TiPlus Technology Paradigm Spine, DE | ODP |
| Oct 7, 2020 | K201453 | Fortilink Cages with TiPlus Technology Paradigm Spine GmbH | MAX |
| Aug 4, 2020 | K201704 | CoFix System Paradigm Spine GmbH | PEK |
| Sep 8, 2016 | K153302 | coflex-IF Paradigm Spine, LLC | PEK |
| May 9, 2012 | K120491 | DSS STABILIZATION SYSTEM-RIGID Paradigm Spine, LLC | MNH |
| Feb 13, 2012 | K112595 | COFLEX-F Paradigm Spine, LLC | KWP |
| Jan 10, 2012 | K113625 | DSS STABILIZATION SYSTEM Paradigm Spine, LLC | NKB |
| Oct 6, 2010 | K093438 | PARADIGM INTERSPINOUS FUSION PLATE Paradigm Spine, LLC | KWP |
| Jul 2, 2010 | K101083 | DSS STABILIZATION SYSTEM Paradigm Spine, LLC | NQP |
| Aug 3, 2009 | K091944 | MODIFICATION TO: DSS STABILIZATION SYSTEM Paradigm Spine, LLC | NQP |
| Jun 19, 2009 | K090099 | DSS STABILIZATION SYSTEM Paradigm Spine, LLC | NKB |
| Mar 20, 2009 | K090408 | MODIFICATION TO: DSS STABILIZATION SYSTEM Paradigm Spine, LLC | NKB |
| Nov 28, 2008 | K080241 | DDS STABILIZATION SYSTEM Paradigm Spine, LLC | NQP |
| Jul 2, 2008 | K071668 | ORTHOBIOM SPINAL SYSTEM Paradigm Spine | MNI |
| May 2, 2008 | K080963 | DSS STABILIZATION SYSTEM Paradigm Spine | NQP |
| Jan 24, 2008 | K072969 | DSS Paradigm Spine, LLC | NQP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||