Orthofix, Inc

86-01xx, 86-02xx, 86-03xx, 86-04xx, 86-05xx  All lot numbers manufactured to date

Orthopedic Devices

2

Yes

Worldwide Distribution: USA (nationwide) and the country of Germany.

Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only || The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A. Degenerative disc disease, B. Spondylolisthesis, C. Trauma, D. Spinal Stenosis, E. Deformities, F. Tumor, G. Pseudoarthrosis, and H. Revision of previous surgery. The Azure Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy and nitinol components. The system is attached to the anterior aspect of the vertebral body by means of screw to to the cervical spine.

Catalog Numbers: 52-6800 & 52-6700; All Lot Numbers

Orthopedic Devices

2

Yes

Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel.

Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). || Product Usage: || The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a longer rod in order to include the new vertebral levels.

(UDI)/Lot: a) (18056099647786) B1102163; (b (18056099647793) B1106912

Orthopedic Devices

2

Yes

U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,

Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)

(UDI)/Lot: a) (18056099647762) B1098805; b) (18056099647779) B1102020

Orthopedic Devices

2

Yes

U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,

T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-02001)

(UDI)/Lot: a) (18056099647663) B1099060; b) (18056099647670) B1099062; c) (18056099647687) B1099066

Orthopedic Devices

2

Yes

U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,

TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025); || c) Large (002-F-01030)