FOCUS

GUDID 00814008028443

PS, MIS-Extend, Cannulated Dual Lead 8.5X40mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00814008028443
• NIH Device Record Key: 61d5b0c3-68d3-4419-9f74-55710a3d45bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOCUS
• Version Model Number: PDM-850-040
• Company DUNS: 047486041
• Company Name: NVISION BIOMEDICAL TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 210-545-3713
• Email: Diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: Diana@nvisionbiomed.com

Device Dimensions

• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter
• Length: 40 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime.
• Special Storage Condition, Specify: Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814008028443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180458

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00814008028443]

Moist Heat or Steam Sterilization

[00814008028443]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-20
• Device Publish Date: 2018-12-15

On-Brand Devices [FOCUS]

• 00814008029822: Tower Dis-Engage Instrument. The FOCUS Pedicle Screw System is intended for use in the non-cerv
• 00814008029815: Small Ratcheting T-Handle. The FOCUS Pedicle Screw System is intended for use in the non-cervic
• 00814008029754: Cross Connector Screw Driver. The FOCUS Pedicle Screw System is intended for use in the non-cer
• 00814008029747: Rod Template. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior
• 00814008029730: Rod, MIS, Lordotic 5.5X130mm. The FOCUS Pedicle Screw System is intended for use in the non-cer
• 00814008029723: Rod, MIS, Lordotic 5.5X120mm. The FOCUS Pedicle Screw System is intended for use in the non-cer
• 00814008029716: Rod, MIS, Lordotic 5.5X110mm. The FOCUS Pedicle Screw System is intended for use in the non-cer
• 00814008029709: Rod, MIS, Lordotic 5.5X100mm. The FOCUS Pedicle Screw System is intended for use in the non-cer
• 00814008029693: Rod, MIS, Lordotic 5.5X90mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
• 00814008029686: Rod, MIS, Lordotic 5.5X80mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
• 00814008029679: Rod, MIS, Lordotic 5.5X70mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
• 00814008029662: Rod, MIS, Lordotic 5.5X65mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
• 00814008029655: Rod, MIS, Lordotic 5.5X60mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
• 00814008029648: Rod, MIS, Lordotic 5.5X55mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
• 00814008029631: Rod, MIS, Lordotic 5.5X50mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
• 00814008029624: Rod, MIS, Lordotic 5.5X45mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
• 00814008029617: Rod, MIS, Lordotic 5.5X40mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
• 00814008029600: Rod, MIS, Lordotic 5.5X35mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
• 00814008029594: Rod, MIS, Lordotic 5.5X30mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
• 00814008029587: PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X110mm. The FOCUS Pedicle Screw System is inte
• 00814008029570: PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X105mm. The FOCUS Pedicle Screw System is inte
• 00814008029563: PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X100mm. The FOCUS Pedicle Screw System is inte
• 00814008029556: PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X95mm. The FOCUS Pedicle Screw System is inten
• 00814008029549: PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X90mm. The FOCUS Pedicle Screw System is inten
• 00814008029532: PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X85mm. The FOCUS Pedicle Screw System is inten
• 00814008029525: PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X80mm. The FOCUS Pedicle Screw System is inten
• 00814008029518: PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X75mm. The FOCUS Pedicle Screw System is inten
• 00814008029501: PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X70mm. The FOCUS Pedicle Screw System is inten
• 00814008029495: PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X65mm. The FOCUS Pedicle Screw System is inten
• 00814008029488: PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X60mm. The FOCUS Pedicle Screw System is inten
• 00814008029471: PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X55mm. The FOCUS Pedicle Screw System is inten
• 00814008029464: PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X50mm. The FOCUS Pedicle Screw System is inten
• 00814008029457: PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X45mm. The FOCUS Pedicle Screw System is inten
• 00814008029440: PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X40mm. The FOCUS Pedicle Screw System is inten
• 00814008029433: PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X35mm. The FOCUS Pedicle Screw System is inten
• 00814008029426: PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X30mm. The FOCUS Pedicle Screw System is inten
• 00814008029419: PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X25mm. The FOCUS Pedicle Screw System is inten
• 00814008029402: PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X60mm. The FOCUS Pedicle Screw System is inten
• 00814008029396: PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X55mm. The FOCUS Pedicle Screw System is inten
• 00814008029389: PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X50mm. The FOCUS Pedicle Screw System is inten
• 00814008029372: PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X45mm. The FOCUS Pedicle Screw System is inten
• 00814008029365: PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X40mm. The FOCUS Pedicle Screw System is inten
• 00814008029358: PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X35mm. The FOCUS Pedicle Screw System is inten
• 00814008029341: PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X30mm. The FOCUS Pedicle Screw System is inten
• 00814008029334: PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X25mm. The FOCUS Pedicle Screw System is inten
• 00814008029327: PS, MIS-Tower Reduction, Cannulated Dual Lead 6.5X60mm. The FOCUS Pedicle Screw System is inten
• 00814008029310: PS, MIS-Tower Reduction, Cannulated Dual Lead 6.5X55mm. The FOCUS Pedicle Screw System is inten
• 00814008029303: PS, MIS-Tower Reduction, Cannulated Dual Lead 6.5X50mm. The FOCUS Pedicle Screw System is inten
• 00814008029297: PS, MIS-Tower Reduction, Cannulated Dual Lead 6.5X45mm. The FOCUS Pedicle Screw System is inten
• 00814008029280: PS, MIS-Tower Reduction, Cannulated Dual Lead 6.5X40mm. The FOCUS Pedicle Screw System is inten