Orthofix Srl

a) 120 MM, Product Code 99-56-22000, Lot No. V1374370 (Lot No. laser marked on products V1369866, V1369865, V1369864), Exp. Date 06/08/2019, UDI 18054242512585;   b) 140 MM, Product Code 99-56-22020, Lot No. V1374298 (Lot No. laser marked on products V1369870, V1369868, V1369869, V1369872, V1369871), Exp. Date 06/07/2019, UDI 18054242512592;   c) 160 MM, Product Code 99-56-22040, Lot No. V1374255 (Lot No. laser marked on products V1370134, V1370136, V1370128, V1370133, V1370132, V1370131), Exp. Date 06/07/2019, Lot No. V1374374 (Lot No. laser marked on products V1370130), Exp. Date 06/08/2019, Lot No. R1065030 (Lot No. laser marked on products V1370134, V1370136, V1370128, V1370133, V1370132, V1370131), Exp. Date 12/16/2021, UDI 18054242512608;   d) 180 MM, Product Code 99-56-22060, Lot No. V1374259 (Lot No. laser marked on products V1370581, V1369468, V1369469, V1369467, V1369466, V1369465, V1369471, V1369470, V1370597), Exp. Date 06/07/2019, UDI 18054242512615;   e) 200 MM, Product Code 99-56-22080, Lot No. V1374361 (Lot No. laser marked on products V1369462, V1371128, V1371074, V1369463, V1370469), Exp. Date 06/08/2019, UDI 18054242512622;   f) 220 MM, Product Code 99-56-22100, Lot No. V1374373 (Lot No. laser marked on products V1369460, V1371250, V1371075), Exp. Date 06/08/2019, UDI 18054242512639

Orthopedic Devices

2

Yes

Worldwide Distribution - US Distribution within Texas., and to the countries of : Australia, Belgium, Chile, Denmark, France, Germany, Israel, Italy, Japan, South Africa, Spain, Sweden, Switzerland and United Kingdom.

TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. || The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system. The system is a metal bone fixation device for stabilization and correction during the normal healing process. The purpose of the TL-HEX System is to provide a solution for deformity correction and keeping the bone segments aligned during the healing process. The device may only be applied by a physician, who is fully responsible for the surgical and post-operative procedures of the system and is able to manage possible mechanical and software limitations. Indications for use for adults and all pediatric subgroups except newborns include: post-traumatic joint contracture which has resulted in loss of range of motion, fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction, open and closed fracture fixation, pseudoarthrosis of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, correction of bony of soft tissue defects, joint arthrodesis, infected fractures or non unions.

Power Drill Torque Limiter: Product Code 99-93568; Lot (Exp Date) V1388296 (12/28/2019), V1388432 (12/29/2019), V1389857 (01/13/2020), V1400707 (05/18/2020), V1400940 (05/23/2020), V1410027 (09/01/2020); UDI: 18054242512318.   Galaxy UNYCO Diaphyseal Tibia Sterile Kit: Product Code 99-93506; Lot (Exp Date) V1389818 (01/12/2020), V1389819 (01/12/2020), V1389886 (02/13/2020), V1399881 (05/10/2020), V1400800 (05/22/2020), V1402023 (06/03/2020), V1405602 (07/17/2020), V1406422 (07/26/2020), V1410082 (09/02/2020), R1412578 (09/28/2020), V1414451 (10/19/2020), V1421785 (02/01/2021), V1425406 (03/13/2021), B1012462 (06/19/2021), B1012776 (06/26/2021), B1019431 (07/05/2021), B1031608 (08/05/2021), B1052165 (10/23/2021), B1049195 (10/25/2021), B1080028 (02/16/2022), B1099157 (04/08/2022), B1107271 (04/09/2022); UDI: 18054242512325.   Galaxy UNYCO Mini Kit Instruments Sterile: Product Code 99-93509; Lot (Exp Date) V1408711 (08/01/2020), V1410026 (09/01/2020), V1422854 (02/14/2021), V1427350 (04/09/2021), V1429217 (04/26/2021), B1083360 (02/20/2022); UDI: 18054242513629.   Galaxy UNYCO Diaphyseal Femur Box: Product Code 99-93790; Lot (Exp Date) B1019281 (04/09/2021); UDI: 1805424515159.   Galaxy UNYCO Knee Bridging Box: Product Code 99-93791; Lot (Exp Date) B1019282 (04/09/2021); UDI: 18054242515166.  Galaxy UNYCO Ankle Bridging Box - Unilateral Frame; Product Code 99-93792; Lot (Exp Date) V140597 (03/21/2020); UDI: 18054242513643.   Galaxy UNYCO Ankle Bridging Box - Delta Frame: Product Code 99-93793; Lot (Exp Date) V1409944 (03/09/2020); UDI: 18054242513650.   Galaxy UNYCO Diaphyseal Tibia Box: Product Code 99-93794; Lot (Exp Date) V1410194 (04/18/2020). UDI: 18054242513667.

Orthopedic Devices

2

Yes

Worldwide Distribution -- US, including the states of CA, FL, & PA; and, the countries of Australia, Germany, Finland, France, Italy, Lithuania, Netherlands, Singapore, South Africa, Sweden, Switzerland, & United Kingdom.

Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. || Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.