PedFuse

GUDID 00190361028185

Ø5-7MM GEN II SET SCREW

SPINEFRONTIER, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190361028185
• NIH Device Record Key: e8c48f63-5b5a-4926-a864-e3acfc23be7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PedFuse
• Version Model Number: 01-80325
• 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

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190361028185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123164

FDA Product Code

• MNI: Orthosis, spinal pedicle fixation

Sterilization

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

[00190361028185]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-16
• Device Publish Date: 2020-03-06

On-Brand Devices [PedFuse]

• 00190361035374: Sliding Washer
• 00190361035367: CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø5.0MM X 50MM
• 00190361035350: CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø5.0MM X 45MM
• 00190361035343: CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø5.0MM X 40MM
• 00190361035336: CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø5.0MM X 35MM
• 00190361035329: CANNULATED, RESPOND-XL SCREW ASSY, ø5.0MM X 50MM
• 00190361035312: CANNULATED, RESPOND-XL SCREW ASSY, ø5.0MM X 45MM
• 00190361035305: CANNULATED, RESPOND-XL SCREW ASSY, ø5.0MM X 40MM
• 00190361035299: CANNULATED, RESPOND-XL SCREW ASSY, ø5.0MM X 35MM
• 00190361035282: CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 80MM
• 00190361035275: CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 75MM
• 00190361035268: CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 70MM
• 00190361035251: CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 65MM
• 00190361035244: CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 60MM
• 00190361035237: CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 55MM
• 00190361035220: CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 50MM
• 00190361035213: CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 45MM
• 00190361035206: CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 40MM
• 00190361035190: CANNULATED,RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 35MM
• 00190361035183: CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø6.0MM X 55MM
• 00190361035176: CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø6.0MM X 50MM
• 00190361035169: CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø6.0MM X 45MM
• 00190361035152: CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø6.0MM X 40MM
• 00190361035145: CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø6.0MM X 35MM
• 00190361035138: CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 80MM
• 00190361035121: CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 75MM
• 00190361035114: CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 70MM
• 00190361035107: CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 65MM
• 00190361035091: CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 60MM
• 00190361035084: CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 55MM
• 00190361035077: CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 50MM
• 00190361035060: CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 45MM
• 00190361035053: CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 40MM
• 00190361035046: CANNULATED,RESPOND-XL SCREW ASSY, ø7.0MM X 35MM
• 00190361035039: CANNULATED, RESPOND-XL SCREW ASSY, ø6.0MM X 55MM
• 00190361035022: CANNULATED, RESPOND-XL SCREW ASSY, ø6.0MM X 50MM
• 00190361035015: CANNULATED, RESPOND-XL SCREW ASSY, ø6.0MM X 45MM
• 00190361035008: CANNULATED, RESPOND-XL SCREW ASSY, ø6.0MM X 40MM
• 00190361034995: CANNULATED, RESPOND-XL SCREW ASSY, ø6.0MM X 35MM
• 00190361034988: Remind Quad-H Solid 6.5x55
• 00190361034971: Remind Quad-H Solid 6.5x50
• 00190361034964: Remind Quad-H Solid 6.5x45
• 00190361034957: Remind Quad-H Solid 6.5x40
• 00190361034940: Remind Quad-H Solid 6.5x35
• 00190361034933: Remind Quad-H Solid RBM 6.5x30
• 00190361034926: Remind Quad-H Solid 6.5x30
• 00190361034919: Remind Quad Solid 6.5x50
• 00190361034902: Remind Quad Solid 6.5x45
• 00190361034896: Remind Quad Solid 6.5x40
• 00190361034889: Remind Quad Solid 6.5x35