PedFuse®

GUDID 00190361009818

PedFuse ReTurn, SLD, 8.0mm x 80mm

SPINEFRONTIER, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190361009818
• NIH Device Record Key: 44d0ba86-928e-4b1e-964a-c5f9bb3f6c2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PedFuse®
• Version Model Number: 01-80050-80
• Company DUNS: 002003243
• Company Name: SPINEFRONTIER, 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: +1(866)914-7717
• Email: customerservice@spinefrontier.com

Device Dimensions

• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190361009818 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092420

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[00190361009818]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-15

On-Brand Devices [PedFuse®]

• 00190361022220: Ø8.0 X 80mm Gen 1 Reset Cannulated Screw
• 00190361022213: Ø8.0 X 75mm Gen 1 Reset Cannulated Screw
• 00190361022206: Ø8.0 X 70mm Gen 1 Reset Cannulated Screw
• 00190361022190: Ø8.0 X 65mm Gen 1 Reset Cannulated Screw
• 00190361022183: Ø8.0 X 60mm Gen 1 Reset Cannulated Screw
• 00190361022176: Ø8.0 X 55mm Gen 1 Reset Cannulated Screw
• 00190361022169: Ø8.0 X 50mm Gen 1 Reset Cannulated Screw
• 00190361022152: Ø8.0 X 45mm Gen 1 Reset Cannulated Screw
• 00190361022145: Ø8.0 X 40mm Gen 1 Reset Cannulated Screw
• 00190361022138: Ø8.0 X 35mm Gen 1 Reset Cannulated Screw
• 00190361022121: Ø8.0 X 30mm Gen 1 Reset Cannulated Screw
• 00190361022084: Remind Quad Solid 6.5x55
• 00190361022077: Remind Quad Solid RBM 6.5x55
• 00190361016601: KRD1 set screw
• 00190361016595: Pedicle Screw Assy, Reduct Tulip, 7x80mm
• 00190361016588: Pedicle Screw Assy, Reduct Tulip, 7x75mm
• 00190361016571: Pedicle Screw Assy, Reduct Tulip, 7x70mm
• 00190361016564: Pedicle Screw Assy, Reduct Tulip, 7x65mm
• 00190361016557: Pedicle Screw Assy, Reduct Tulip, 7x60mm
• 00190361016540: Pedicle Screw Assy, Reduct Tulip, 7x55mm
• 00190361016533: Pedicle Screw Assy, Reduct Tulip, 7x50mm
• 00190361016526: Pedicle Screw Assy, Reduct Tulip, 7x45mm
• 00190361016519: Pedicle Screw Assy, Reduct Tulip, 7x40mm
• 00190361016502: Pedicle Screw Assy, Reduct Tulip, 7x35mm
• 00190361016496: Pedicle Screw Assy, Reduct Tulip, 7x30mm
• 00190361016489: Pedicle Screw Assy Reduction Tulip, 6x55
• 00190361016472: Pedicle Screw Assy Reduction Tulip, 6x50
• 00190361016465: Pedicle Screw Assy Reduction Tulip, 6x45
• 00190361016458: Pedicle Screw Assy Reduction Tulip, 6x40
• 00190361016441: Pedicle Screw Assy Reduction Tulip, 6x35
• 00190361016434: Pedicle Screw Assy Reduction Tulip, 6x30
• 00190361016427: Pedicle Screw Assy Reduction Tulip, 5x50
• 00190361016410: Pedicle Screw Assy Reduction Tulip, 5x45
• 00190361016403: Pedicle Screw Assy Reduction Tulip, 5x40
• 00190361016397: Pedicle Screw Assy Reduction Tulip, 5x35
• 00190361016380: Pedicle Screw Assy Reduction Tulip, 5x30
• 00190361016373: PedFuse, Adjustible Cross Connector, 35mm
• 00190361016366: PedFuse, Adjustible Cross Connector, 30mm
• 00190361016359: PedFuse, Rod, Lordotic, 5.5mm X 65mm
• 00190361016342: PedFuse, Rod, Straight, 5.5mm X 65mm
• 00190361016335: PedFuse, Rod, Straight, 5.5mm X 100mm
• 00190361016328: Pedicle Screw Assy, 9.0mm x 80mm
• 00190361016311: Pedicle Screw Assy, 9.0mm x 75mm
• 00190361016304: Pedicle Screw Assy, 9.0mm x 70mm
• 00190361016298: Pedicle Screw Assy, 9.0mm x 65mm
• 00190361016281: Pedicle Screw Assy, 9.0mm x 60mm
• 00190361016274: Pedicle Screw Assy, 9.0mm x 55mm
• 00190361016267: Pedicle Screw Assy, 9.0mm x 50mm
• 00190361016250: Pedicle Screw Assy, 9.0mm x 45mm
• 00190361016243: Pedicle Screw Assy, 9.0mm x 40mm