InSpan®

GUDID 00190361039556

12mm InSpan Sizing Trial

SPINEFRONTIER, INC.

Interspinous spinal fixation implant

• Primary Device ID: 00190361039556
• NIH Device Record Key: c247c39b-0ceb-40d9-bc1a-3bef196c102f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InSpan®
• Version Model Number: 11-60082-12
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00190361039556 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102020

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00190361039556]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-10-05

On-Brand Devices [InSpan®]

• 00190361039570: 16mm InSpan Sizing Trial
• 00190361039563: 14mm InSpan Sizing Trial
• 00190361039556: 12mm InSpan Sizing Trial
• 00190361039549: 10mm InSpan Sizing Trial
• 00190361039532: 8mm InSpan Sizing Trial
• 00190361000976: ISP Plate, Assy, 16x37mm
• 00190361000969: ISP Plate, Assy, 14x37mm
• 00190361000952: ISP Plate, Assy, 12x37mm
• 00190361000945: ISP Plate, Assy, 10x37mm
• 00190361000938: ISP Plate, Assy, 8x37mm
• 00190361000921: ISP Plate, Assy, 16x39mm
• 00190361000914: ISP Plate, Assy, 14x39mm
• 00190361000907: ISP Plate, Assy, 12x39mm
• 00190361000891: ISP Plate, Assy, 10x39mm
• 00190361000884: ISP Plate, Assy, 8x39mm
• 00190361000877: ISP Plate, Assy, 16x41mm
• 00190361000860: ISP Plate, Assy, 14x41mm
• 00190361000853: ISP Plate, Assy, 12x41mm
• 00190361000846: ISP Plate, Assy, 10x41mm
• 00190361000839: ISP Plate, Assy, 8x41mm
• 00190361000822: ISP Plate, Assy, 16x43mm
• 00190361000815: ISP Plate, Assy, 14x43mm
• 00190361000808: ISP Plate, Assy, 12x43mm
• 00190361000792: ISP Plate, Assy, 10x43mm
• 00190361000785: ISP Plate, Assy, 8x43mm
• 00190361000778: ISP Plate, Assy, 16x45mm
• 00190361000761: ISP Plate, Assy, 14x45mm
• 00190361000754: ISP Plate, Assy, 12x45mm
• 00190361000747: ISP Plate, Assy, 10x45mm
• 00190361000730: ISP Plate, Assy, 8x45mm
• 00190361000723: M5 Set Screw, ISP Plate
• 00190361000716: ISP Plate, 16x37mm
• 00190361000709: ISP Plate, 14x37mm
• 00190361000693: ISP Plate, 12x37mm
• 00190361000686: ISP Plate, 10x37mm
• 00190361000679: ISP Plate, 8x37mm
• 00190361000662: ISP Plate, 16x39mm
• 00190361000655: ISP Plate, 14x39mm
• 00190361000648: ISP Plate, 12x39mm
• 00190361000631: ISP Plate, 10x39mm
• 00190361000624: ISP Plate, 8x39mm
• 00190361000617: ISP Plate, 16x41mm
• 00190361000600: ISP Plate, 14x41mm
• 00190361000594: ISP Plate, 12x41mm
• 00190361000587: ISP Plate, 10x41mm
• 00190361000570: ISP Plate, 8x41mm
• 00190361000563: ISP Plate, 16x43mm
• 00190361000556: ISP Plate, 14x43mm
• 00190361000549: ISP Plate, 12x43mm
• 00190361000532: ISP Plate, 10x43mm