InSpan

GUDID 00190361024620

SLIM, INSPAN, ISP PLATE ASSEMBLY

SPINEFRONTIER, INC.

Interspinous spinal fixation implant

• Primary Device ID: 00190361024620
• NIH Device Record Key: d61831cd-8265-4ede-8398-ea64fb3c75ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InSpan
• Version Model Number: 01-61100-1239
• 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

• Length: 39 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190361024620 [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

[00190361024620]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-16
• Device Publish Date: 2019-09-06

On-Brand Devices [InSpan]

• 00190361024644: SLIM, INSPAN, ISP PLATE ASSEMBLY
• 00190361024637: SLIM, INSPAN, ISP PLATE ASSEMBLY
• 00190361024620: SLIM, INSPAN, ISP PLATE ASSEMBLY
• 00190361024613: SLIM, INSPAN, ISP PLATE ASSEMBLY
• 00190361024606: SLIM, INSPAN, ISP PLATE ASSEMBLY
• 00190361024590: SLIM, INSPAN, ISP PLATE ASSEMBLY
• 00190361028291: SLIM, INSPAN, ISP PLATE ASSEMBLY
• 00190361028284: SLIM, INSPAN, ISP PLATE ASSEMBLY