Altus Spine HA Pedicle Screw System

GUDID 00843210157153

Polyaxial Pedicle Screw, HA Coated.

Altus Spine, LLC

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• Primary Device ID: 00843210157153
• NIH Device Record Key: 4e10745a-0fea-4545-b368-355e8c333f11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Altus Spine HA Pedicle Screw System
• Version Model Number: 811-8545HA
• Company DUNS: 078331322
• Company Name: Altus Spine, 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: false
• 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	00843210157153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200922

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

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: 2023-04-12
• Device Publish Date: 2023-04-04

On-Brand Devices [Altus Spine HA Pedicle Screw System]

• 00843210157214: Polyaxial Pedicle Screw, HA Coated.
• 00843210157207: Polyaxial Pedicle Screw, HA Coated.
• 00843210157191: Polyaxial Pedicle Screw, HA Coated.
• 00843210157184: Polyaxial Pedicle Screw, HA Coated.
• 00843210157177: Polyaxial Pedicle Screw, HA Coated.
• 00843210157160: Polyaxial Pedicle Screw, HA Coated.
• 00843210157153: Polyaxial Pedicle Screw, HA Coated.
• 00843210157146: Polyaxial Pedicle Screw, HA Coated.
• 00843210157139: Polyaxial Pedicle Screw, HA Coated.
• 00843210157122: Polyaxial Pedicle Screw, HA Coated.
• 00843210157115: Polyaxial Pedicle Screw, HA Coated.
• 00843210157108: Polyaxial Pedicle Screw, HA Coated.
• 00843210157092: Polyaxial Pedicle Screw, HA Coated.
• 00843210157085: Polyaxial Pedicle Screw, HA Coated.
• 00843210157078: Polyaxial Pedicle Screw, HA Coated.
• 00843210157061: Polyaxial Pedicle Screw, HA Coated.
• 00843210157054: Polyaxial Pedicle Screw, HA Coated.
• 00843210157047: Polyaxial Pedicle Screw, HA Coated.
• 00843210157030: Polyaxial Pedicle Screw, HA Coated.
• 00843210157023: Polyaxial Pedicle Screw, HA Coated.
• 00843210157016: Polyaxial Pedicle Screw, HA Coated.
• 00843210157009: Polyaxial Pedicle Screw, HA Coated.
• 00843210156996: Polyaxial Pedicle Screw, HA Coated.
• 00843210156989: Polyaxial Pedicle Screw, HA Coated.
• 00843210156972: Polyaxial Pedicle Screw, HA Coated.
• 00843210156965: Polyaxial Pedicle Screw, HA Coated.
• 00843210156958: Polyaxial Pedicle Screw, HA Coated.
• 00843210156941: Polyaxial Pedicle Screw, HA Coated.
• 00843210156934: Polyaxial Pedicle Screw, HA Coated.
• 00843210156927: Polyaxial Pedicle Screw, HA Coated
• 00843210156910: Polyaxial Pedicle Screw, HA Coated.
• 00843210156903: Polyaxial Pedicle Screw, HA Coated.
• 00843210156897: Polyaxial Pedicle Screw, HA Coated.
• 00843210156880: Polyaxial Pedicle Screw, HA Coated.
• 00843210156873: Polyaxial Pedicle Screw, HA Coated.
• 00843210156866: Polyaxial Pedicle Screw, HA Coated.
• 00843210156859: Polyaxial Pedicle Screw, HA Coated.
• 00843210156842: Polyaxial Pedicle Screw, HA Coated.
• 00843210156835: Polyaxial Pedicle Screw, HA Coated.
• 00843210156828: Polyaxial Pedicle Screw, HA Coated.
• 00843210156811: Polyaxial Pedicle Screw, HA Coated.
• 00843210156804: Polyaxial Pedicle Screw, HA Coated.
• 00843210156798: Polyaxial Pedicle Screw, HA Coated.
• 00843210156781: Polyaxial Pedicle Screw, HA Coated.
• 00843210156774: Polyaxial Pedicle Screw, HA Coated.
• 00843210156767: Polyaxial Pedicle Screw, HA Coated.
• 00843210156750: Polyaxial Pedicle Screw, HA Coated.
• 00843210156743: Polyaxial Pedicle Screw, HA Coated.
• 00843210156736: Polyaxial Pedicle Screw, HA Coated.
• 00843210169002: Solid Polyaxial Pedicle Screw, HA Coated.