Facet Screw System 35-S4540-X

GUDID 00815362023495

4.5 x 40mm Non-Cannulated Screw

PRECISION SPINE, INC.

Trans-facet-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00815362023495
• NIH Device Record Key: 5aaa3610-62a7-4a99-8e94-bacf9bcdbf77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Facet Screw System
• Version Model Number: 35-S4540-X
• Catalog Number: 35-S4540-X
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815362023495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130863

FDA Product Code

• MRW: System, Facet Screw Spinal Device

Sterilization

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

[00815362023495]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-09
• Device Publish Date: 2019-04-01

On-Brand Devices [Facet Screw System]

• 00815362023686: Facet Screw Tray (Empty)
• 00815362023662: Screw Inserter, AO connection
• 00815362023655: Tap, AO connection
• 00815362023648: Drill, AO connection
• 00815362023631: 12mm Dilator
• 00815362023624: 8mm Dilator
• 00815362023617: Handle, Palm, Cannulated, AO connection
• 00815362023600: Introducer with handle
• 00815362023594: K-Wire, 1.4mm dia x 23.5" long, partially threaded tip
• 00815362023587: K-Wire, 1.4mm dia x 23.5" long, trocar tip
• 00815362023570: 5.0 x 50mm Non-Cannulated Screw
• 00815362023563: 5.0 x 45mm Non-Cannulated Screw
• 00815362023556: 5.0 x 40mm Non-Cannulated Screw
• 00815362023549: 5.0 x 35mm Cannulated Screw
• 00815362023532: 5.0 x 30mm Non-Cannulated Screw
• 00815362023525: 5.0 x 25mm Non-Cannulated Screw
• 00815362023518: 4.5 x 50mm Non-Cannulated Screw
• 00815362023501: 4.5 x 45mm Non-Cannulated Screw
• 00815362023495: 4.5 x 40mm Non-Cannulated Screw
• 00815362023488: 4.5 x 35mm Non-Cannulated Screw
• 00815362023471: 4.5 x 30mm Non-Cannulated Screw
• 00815362023464: 4.5 x 25mm Non-Cannulated Screw
• 00815362023457: 5.0 x 50mm Cannulated Screw
• 00815362023440: 5.0 x 45mm Cannulated Screw
• 00815362023433: 5.0 x 40mm Cannulated Screw
• 00815362023426: 5.0 x 35mm Cannulated Screw
• 00815362023419: 5.0 x 30mm Cannulated Screw
• 00815362023402: 5.0 x 25mm Cannulated Screw
• 00815362023396: 4.5 x 50mm Cannulated Screw
• 00815362023389: 4.5 x 45mm Cannulated Screw
• 00815362023372: 4.5 x 40mm Cannulated Screw
• 00815362023365: 4.5 x 35mm Cannulated Screw
• 00815362023358: 4.5 x 30mm Cannulated Screw
• 00815362023341: 4.5 x 25mm Cannulated Screw
• 00840019936231: Facet Screw Tray