X-Spine Systems, Inc.
X-Spine Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2018, with 7 FDA device recalls on record.
Top product codes for X-Spine Systems, Inc.
FDA recalls by X-Spine Systems, Inc.
- Z-0127-2017 — Calix T PEEK Lumbar System, TLIF Trial
- Z-0125-2017 — Calix P PEEK Lumbar System, PLIF Trial
- Z-0126-2017 — Calix T PEEK Lumbar System, TLIF Rasp
- Z-0124-2017 — Calix P PEEK Lumbar System, PLIF Rasp
- Z-1823-2015 — Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
- Z-1512-2015 — Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
- Z-2136-2014 — Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by X-Spine Systems, Inc.
- K173832 — InTice-C Porous Ti Cervical Interbody System
- K180153 — X-spine Cortical Bone Screw System
- K170119 — Calix Lumbar Spinal Implant System
- K171567 — IRIX-A Lumbar Integrated Fusion System
- K171075 — Calix-C Cervical Interbody Spacer
- K170224 — Spider Cervical Plating System
- K170530 — Butrex Lumbar Buttress Plating System
- K160959 — Xsert Lumbar Expandable Interbody System
- K162944 — Irix-C Cervical Integrated Fusion System
- K160428 — Certex Spinal Fixation System
- K160114 — Xspan Laminoplasty Fixation System
- K152132 — X-spine Pedicle Screw System
- K150834 — Atrax Anterior Cervical Plating System
- K133947 — IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
- K140079 — SILEX SACROILIAC JOINT FUSION SYSTEM
- K133094 — CERTEX OCT SPINAL IMPLANT SYSTEM
- K131350 — CALIX LUMBAR SPINAL IMPLANT SYSTEM
- K131951 — IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
- K130438 — AXLE INTERSPINOUS FUSION SYSTEM
- K123932 — ZYGAFIX SPINAL FACET SCREW SYSTEM
- K123702 — SILEX SACROILIAC JOINT FUSION SYSTEM
- K122163 — CERTEX SPINAL IMPLANT SYSTEM
- K120832 — FORTEX PEDICLE SCREW SYSTEM
- K112592 — AXLE PEEK INTERSPINOUS FUSION SYSTEM
- K112036 — CALIX PC SPINAL IMPLANT SYSTEM
- K101471 — AXLE INTERSPINOUS FUSION SYSTEM
- K100154 — FIXCET SPINAL FACET SCREW SYSTEM
- K092360 — ACP4 SPINAL IMPLANT SYSTEM
- K090224 — FORTEX PEDICLE SCREW SYSTEM
- K083637 — CALIX SPINAL IMPLANT SYSTEM
- K072943 — BUTREX BUTTRESS PLATING SYSTEM
- K072282 — CAPLESS LI PEDICLE SCREW SYSTEM
- K052847 — CAPLESS PEDICLE SCREW SYSTEM
- K052292 — SPIDER CERVICAL PLATING (SCP) SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.