Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list X-Spine Systems with 35 510(k) clearances and 7 device recalls. The most recent is a 510(k) clearance dated May 17, 2018: InTice™-C Porous Ti Cervical Interbody System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 17, 2018 | InTice™-C Porous Ti Cervical Interbody SystemK173832 · ODP | 510(k) clearances |
| Mar 15, 2018 | X-spine Cortical Bone Screw SystemK180153 · NKB | 510(k) clearances |
| Sep 29, 2017 | Calix Lumbar Spinal Implant SystemK170119 · MAX | 510(k) clearances |
| Aug 28, 2017 | IRIX-A Lumbar Integrated Fusion SystemK171567 · OVD | 510(k) clearances |
| Aug 1, 2017 | Calix-C Cervical Interbody SpacerK171075 · ODP | 510(k) clearances |
| Jul 6, 2017 | Spider Cervical Plating SystemK170224 · KWQ | 510(k) clearances |
| Mar 22, 2017 | Butrex Lumbar Buttress Plating SystemK170530 · KWQ | 510(k) clearances |
| Nov 17, 2016 | Xsert Lumbar Expandable Interbody SystemK160959 · MAX | 510(k) clearances |
| May 17, 2016 | Calix T PEEK Lumbar System, TLIF TrialClass II · The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserte | Device recalls |
| May 17, 2016 | Calix P PEEK Lumbar System, PLIF TrialClass II · The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserte | Device recalls |
| May 17, 2016 | Calix P PEEK Lumbar System, PLIF RaspClass II · The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserte | Device recalls |
| May 17, 2016 | Calix T PEEK Lumbar System, TLIF RaspClass II · The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserte | Device recalls |
| Apr 7, 2015 | Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 9Class II · The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length. | Device recalls |
| Mar 11, 2015 | Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblClass II · One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x | Device recalls |
| Jul 11, 2014 | Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgClass II · Revision B of the tissue shields of the device was 7 mm longer than the previous design. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
