DePuy Spine, Inc.

Not lot coded

General and Plastic Surgery Devices

1

No

Nationwide distribution: USA including states of: AR, AZ, CA, FL, HI, IA, IL, KY, LA, MA, MI, MN, MO, NC, NY OH, PA, TN, TX, VA, and WA.

Depuy Spine Mountaineer OCT Spinal System Screw Caddy, Non Sterile || Product Code: 2883-90-420 || The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screws prior to use in surgery. Further, the caddy provides a means to organize the screws in accordance with the length of the screws.

Not lot coded

General and Plastic Surgery Devices

1

No

Nationwide distribution: USA including states of: AR, AZ, CA, FL, HI, IA, IL, KY, LA, MA, MI, MN, MO, NC, NY OH, PA, TN, TX, VA, and WA.

Depuy Spine Mountaineer OCT Caddy Set, Non-Sterile || Product Code: 2883-90-000 || The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screws prior to use in surgery. Further, the caddy provides a means to organize the screws in accordance with the length of the screws.

Lot Code: HLPB4F

Orthopedic Devices

1

No

Worldwide distribution: USA including states of: AZ, IA, LA, TX, NE, NJ ,NY, PA, VA, and WA; and countries of: Canada, Australia, Belgium, France,Hungary, Italy, Malaysia, Solvenia, UK, South Africa, Switzerland, and UAE.

Confidence¿ Introducer Needle Side Hole 13G x 4-Inch || Product Code: 2839-04-413 || The Confidence Needles are supplied sterile. They are used to place bone cement percutaneously at a desired location. They come in a variety of sizes (length and diameter) and configurations (Bevel tip, Diamond tip). The cement extrudes from the end of the cannulated needle with the exception of the side hole needle which extrudes cement from a portal on the side of the tube near the distal end. The needle is placed under fluoroscopy prior to cement delivery. The needle is also sometimes used in MIS cases to place the guide wire that is used to assist in the placement of the pedicle screw.

Lot Code: HLPB4G

Orthopedic Devices

1

No

Worldwide distribution: USA including states of: AZ, IA, LA, TX, NE, NJ ,NY, PA, VA, and WA; and countries of: Canada, Australia, Belgium, France,Hungary, Italy, Malaysia, Solvenia, UK, South Africa, Switzerland, and UAE.

Confidence¿ Diamond Tip Introducer Needle 11G x 6-Inch || Product Code: 2839-03-611 || The Confidence Needles are supplied sterile. They are used to place bone cement percutaneously at a desired location. They come in a variety of sizes (length and diameter) and configurations (Bevel tip, Diamond tip). The cement extrudes from the end of the cannulated needle with the exception of the side hole needle which extrudes cement from a portal on the side of the tube near the distal end. The needle is placed under fluoroscopy prior to cement delivery. The needle is also sometimes used in MIS cases to place the guide wire that is used to assist in the placement of the pedicle screw.

Product Code: 2894-10-300; Lot Number: 1208NT.

Orthopedic Devices

2

Yes

Nationwide Distribution -- Including states of MD, PA, NC, MO, NV, AZ, WI and CT.

DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. || Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.