Interventional Spine Inc

CATALOG NO. 9045-01, LOT #'s: 050709-8, 050809-C, 051209-D, 060209-A, 060809-C, 061709-C, 062009-0,  CATALOG NO. 9045-02, LOT #'s: 050809-B, 051309-8,060809-8, 061 709-0,060209-A

Orthopedic Devices

Unclassified

Yes

Nationwide Distribution including CO, CT, FL, KY, LA, MA, MO, NC, NY, OK, OR, TN, TX, VA & WI

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.

LOT #'s: 040209-B, 041309-B

Orthopedic Devices

1

No

Nationwide Distribution including the states of to NC, NY, TN & VA

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.

LOT #'s: 040309-A, 041409-A

Orthopedic Devices

1

No

Nationwide Distribution including the states of to NC, NY, TN & VA

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.

DRIVER CATALOG NO. 6112; 050507A, 061509A, 071808A, 112507A, 042709E

Orthopedic Devices

1

No

Word wide Distribution: (USA) Nationwide including the states of CO, CT, FL, KY, LA, MA, NC, NY, OK, OR, TN, TX, VA, and WI; and the countries of Italy, Spain, Turkey, and the U.K.

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.

CATALOG #'s: 9039-01LOT NUMBERS: 092707-01, 102907, 102907-02 thru -03, 120107-01 thru -10, 050208-21 thru -30, 050208-15 thru -16, 050108-01, 041708-01, 050208-11 thru -20, 060208-01 thru -10, 050208-41 thru -47  CATALOG #'s: 9039-02 LOT NUMBERS: 050208-11 thru -20, 050108-11

Orthopedic Devices

1

No

Word wide Distribution: (USA) Nationwide including the states of CO, CT, FL, KY, LA, MA, NC, NY, OK, OR, TN, TX, VA, and WI; and the countries of Italy, Spain, Turkey, and the U.K.

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.