Interventional Spine, Inc.

• MAX — Orthopedic6 devices
• MRW — Unknown2 devices

• Z-0941-2017 — G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).Class II·Terminated·2016-11-22

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.

• K160464 — Opticage(R) Expandable Interbody Fusion DeviceCode MAX·2016-04-04
• K152156 — Opticage Expandable Interbody Fusion DeviceCode MAX·2015-10-19
• K140716 — OPTICAGE EXPANDABLE INTERBODY FUSION DEVICECode MAX·2014-11-24
• K133583 — OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070Code MAX·2014-02-10
• K132479 — OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00Code MAX·2013-09-19
• K113527 — OPTICAGE INTERBODY FUSION DEVICECode MAX·2012-01-20
• K090767 — PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZERCode MRW·2009-06-11
• K082795 — SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANTCode MRW·2008-12-12