Company ยท US
Interventional Spine Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2016. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 4, 2016 | K160464 | Opticage(R) Expandable Interbody Fusion Device Interventional Spine, Inc. | MAX |
| Oct 19, 2015 | K152156 | Opticage Expandable Interbody Fusion Device Interventional Spine, Inc. | MAX |
| Nov 24, 2014 | K140716 | OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE Interventional Spine, Inc. | MAX |
| Feb 10, 2014 | K133583 | OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070 Interventional Spine, Inc. | MAX |
| Sep 19, 2013 | K132479 | OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 Interventional Spine, Inc. | MAX |
| Jan 20, 2012 | K113527 | OPTICAGE INTERBODY FUSION DEVICE Interventional Spine, Inc. | MAX |
| Jun 11, 2009 | K090767 | PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER Interventional Spine, Inc. | MRW |
| Dec 12, 2008 | K082795 | SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT Interventional Spine, Inc. | MRW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2017 | Interventional Spine Inc 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 interverte Terminated |
MAX | K152156 K160464 |
| Jan 11, 2012 | Interventional Spine Inc 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, PERP Terminated |
HTW | None listed |
| Jan 11, 2012 | Interventional Spine Inc 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 Terminated |
HTW | None listed |
| Oct 13, 2011 | Interventional Spine Inc 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. T Terminated |
HXX | None listed |
| Oct 13, 2011 | Interventional Spine Inc 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. S Terminated |
HXX | None listed |
| Oct 13, 2011 | Interventional Spine Inc 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. Terminated |
HXX | None listed |
| Aug 18, 2011 | Interventional Spine Inc 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 Terminated |
MRW | K043351 |
| Aug 18, 2011 | Interventional Spine Inc 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 a Terminated |
MRW | K062391 |
| Jul 1, 2011 | Interventional Spine Inc 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 Terminated |
HXI | None listed |
| Jul 1, 2011 | Interventional Spine Inc 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 Terminated |
HXI | None listed |