Interventional Spine, Inc.
Irvine, CA, US
Interventional Spine, Inc. appears in FDA device records in Irvine, CA. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 10 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Interventional Spine, Inc. between 2008 and 2016. The busiest year on record is 2014, with 2. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K160464 | Opticage(R) Expandable Interbody Fusion Device | MAX | Substantially Equivalent | |
| K152156 | Opticage Expandable Interbody Fusion Device | MAX | Substantially Equivalent | |
| K140716 | OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE | MAX | Substantially Equivalent | |
| K133583 | OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070 | MAX | Substantially Equivalent | |
| K132479 | OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 | MAX | Substantially Equivalent | |
| K113527 | OPTICAGE INTERBODY FUSION DEVICE | MAX | Substantially Equivalent | |
| K090767 | PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER | MRW | Unknown | |
| K082795 | SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT | MRW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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). | During implantation, the proximal end of the device could separate if the angle between the device and insertion instrument is too steep. This separation will prevent the device from expanding. | Class II | Terminated | |
| Z-2719-2011 | PERPOS PLS SYSTEM, CATALOG NO. 9045-02 A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided in Appendix A and other labeling, including instructions for use, is provided in Appendix B. | This recall has been initiated due to K-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. Removing the K-wire during a procedure may dislocate the implant resulting in the implant loosening or being pulled out or position. Use of this product may result in a delay of the surgical procedure and/or pull-out of the facet screw | Terminated | ||
| Z-2718-2011 | PERPOS PLS SYSTEM, CATALOG NO. 9045-01 A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided in Appendix A and other labeling, including instructions for use, is provided in Appendix B. | This recall has been initiated due to K-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw. Removing the K-wire during a procedure may dislocate the implant resulting in the implant loosening or being pulled out or position. Use of this product may result in a delay of the surgical procedure and/or pull-out of the facet screw | Terminated | ||
| Z-3034-2011 | Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of the Single Use PERPOS PLS System (9045-01 and 9045-02). The labeling and instructions for use for the 4.5mm BONE-LOK PLS a Implant (9024-00) are provided in Appendix C. | This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver rather than the compression tool. Use of this product may result in less than optimal compression leading to pseudoarthrosis, non-union or facet pain. | Terminated | ||
| Z-3033-2011 | PERPOS PLS, CATALOG #'s 9045-01 & 9045-02 A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. | This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver rather than the compression tool. Use of this product may result in less than optimal compression leading to pseudoarthrosis, non-union or facet pain. | Terminated | ||
| Z-0047-2012 | PERPOS Driver; Catalog # 6112 Interventional Spine, Inc. A cannulated, driver to be used over a K-wire to engage the head of the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) and drive it into the bone. The PERPOS Driver (61 12) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02), a component of the Reusable BONE-LOK PLS System (9039-01, 9039-02), or as a stand-alone tool. | This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone. Use of this product may result in a delay of the surgical procedure | Terminated | ||
| Z-0046-2012 | Reusable BONE-LOK PLS System; Catalog #'s: 9039-01 and 9039-02. Interventional Spine, Inc. A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints. Sold in Europe. | This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone. Use of this product may result in a delay of the surgical procedure | Terminated | ||
| Z-0045-2012 | PERPOS PLS System, Single Use; CATALOG #'s 9045-01 & 9045-02. Interventional Spine, Inc. A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints. | This recall has been initiated due to drivers that may contain a burr in the distal tip preventing full seating of the driver onto the head of the facet screw, resulting in difficulty screwing the facet screw into the bone. Use of this product may result in a delay of the surgical procedure | Terminated | ||
| Z-0420-2012 | Single Use PERPOS PLS System, Catalog #9045-01 Catalog#9045-01 for Single Use PERPOS PLS System- a sterile, medical device kit consisting of the components: PERPOS Access Needle, PERPOS K-Wires, PERPOS 2-in-1 Drill, PERPOS Tap, PERPOS Device Driver, 4.5mm BONE-LOK PLS Implant, and PERPOS Pull Pin Remover. The kit is used by medical professions to stablize the spine as an aid to fusion through immobilization of the facet joints. | The recall was intiated because Interventional Spine has confirmed that the PERPOS 2-in-1 Drill (6070) manufactured by a contract manufacturer for Interventional Spine, Inc., may break during use. | Terminated | ||
| Z-0419-2012 | PERPOS 2-in-1 Drills, Catalog #6070 Component Part #6070 for PERPOS 2-in-1 Drill-a canulated, 2 step drill to be used over a K-wire to remove bone prior to the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) being placed. The PERPOS 2-in-1 Drill (6070) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02) or as a stand-alone tool. | The recall was intiated because Interventional Spine has confirmed that the PERPOS 2-in-1 Drill (6070) manufactured by a contract manufacturer for Interventional Spine, Inc., may break during use. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain