INGENIX

GUDID 00843672101725

Polyax Deformity Screw Kit 6.5x30mm for 5.5mm Rod

INGENIUMSPINE, LLC

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00843672101725
• NIH Device Record Key: b341f3a1-9f3c-44db-882d-20b2b379cb36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INGENIX
• Version Model Number: 55056530
• Company DUNS: 082805471
• Company Name: INGENIUMSPINE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	00843672101725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241258

FDA Product Code

• KNB: Instrument, Destructive, Fetal, Obstetric

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-04
• Device Publish Date: 2025-02-24

On-Brand Devices [INGENIX]

• 00843672101657: Polyax screw 7.5x80mm for 5.5 rod
• 00843672101640: Polyax screw 7.5x70mm for 5.5 rod
• 00843672101633: Polyax def screw 7.5x80mm for 5.5 rod
• 00843672101626: Polyax def screw 7.5x75mm for 5.5 rod
• 00843672101619: Polyax def screw 7.5x70mm for 5.5 rod
• 00843672101602: Polyax def screw 7.5x65mm for 5.5 rod
• 00843672101596: Polyax DEF Screw 7.5x60mm for 5.5mm Rod
• 00843672101671: Polyax Deformity Screw Kit 5.5x35mm for 5.5 Rod
• 00843672101664: Polyax Deformity Screw Kti 5.5x30 for 5.5mm Rod
• 00843672101886: Polyax Deformity Screw Kit 7.5x80mm for 5.5mm Rod
• 00843672101879: Polyax Deformity Screw Kit 7.5x75mm for 5.5mm Rod
• 00843672101862: Polyax Deformity Screw Kit 7.6x70mm for 5.5mm Rod
• 00843672101855: Polyax Deformity Screw Kit 7.5x65mm for 5.5mm Rod
• 00843672101848: Polyax Deformity Screw Kit 7.5x60mm for 5.5mm Rod
• 00843672101831: Polyax Deformity Screw Kit 7.5x55mm for 5.5mm Rod
• 00843672101817: Polyax Deformity Screw Kit 7.5x45mm for 5.5mm Rod
• 00843672101800: Polyax Deformity Screw Kit 7.5x40mm for 5.5mm Rod
• 00843672101794: Polyax Deformity Screw Kit 7.5x35mm for 5.5mm Rod
• 00843672101787: Polyax Deformity Screw Kit 7.5x30mm for 5.5mm Rod
• 00843672101770: Ployax Deformity Screw Kit 6.5x55mm for 5.5mm Rod
• 00843672101763: PolyAx Deformity Screw Kit 6.5x45mm fro 5.5mm ROd
• 00843672101756: Polyax Deformity Screw Kit 6.5x40mm for 5.5mm Rod
• 00843672101749: Polyax Deformity Screw 6.5x40mm Screw kit for 5.5mm Rod
• 00843672101732: Polyax Deformity Screw Kit 6.5x35 for 5.5mm Rod
• 00843672101725: Polyax Deformity Screw Kit 6.5x30mm for 5.5mm Rod
• 00843672101718: Polyax Deformity Screw Kit 5.5x55mm for 5.5mm Rid
• 00843672101701: Polyax Deformity Screw Kit 5.5x50 for 5.5mm Rod
• 00843672101695: Polyax Deformity Kit 5.5x45 for 5.5mm Rid
• 00843672101688: Polyax Deformity Screw Kit 5.5x40mm for 5.5mm Rod
• 00843672101824: Polyax Deformity Screw Kit 7.5x50mm for 5.5mm Rod