CAPLOX II PEDICLE SCREW SYSTEM— 510(k) K120292

Clearance details

Applicant

Captiva Spine, Inc.

Product code

Code MNI

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2012-01-31

Decision date

2012-04-13

Decision

Substantially Equivalent

Clearance type

Special

Location

Apple Valley, MN, US

• K171497 — Mikron Spinal Fixation System2017-10-12
• K160731 — LumFix Spinal Fixation Sytem2016-10-04
• K151458 — Double Medical Universal Spine System2016-08-22
• K153273 — MySpine Pedicle Screw Placement Guides - LP2016-06-29
• K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System2016-04-04

• K193270 — CapLOX II®/TowerLOX® MIS Pedicle Screw System2020-01-31
• K181229 — TirboLOX-C Cervical IBFD2018-09-19
• K180990 — TirboLOX-L Lumbar IBFD2018-08-13
• K180475 — CapLOX II® / TowerLOX® MIS Pedicle Screw System2018-03-19
• K111115 — CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM2011-09-13

Injury

641

Total

641

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0413-2013 — CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.Class II·Terminated·Captiva Spine, Inc·20120920

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120292.