Sochi

GUDID 00843210167992

Rod to Rod Connector, Set Screw

Altus Spine, LLC

Spinal bone set screw

• Primary Device ID: 00843210167992
• NIH Device Record Key: e34c57dd-de6c-4cd0-afaf-80733552e540
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sochi
• Version Model Number: A16-23-0000
• 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: false
• Manufacturing Date: true
• 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: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com
• Phone: 610-355-4156
• Email: QARA@Altus-Spine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843210167992 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210887

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[00843210167992]

Moist Heat or Steam Sterilization

[00843210167992]

Moist Heat or Steam Sterilization

[00843210167992]

Moist Heat or Steam Sterilization

[00843210167992]

Moist Heat or Steam Sterilization

[00843210167992]

Moist Heat or Steam Sterilization

[00843210167992]

Moist Heat or Steam Sterilization

[00843210167992]

Moist Heat or Steam Sterilization

[00843210167992]

Moist Heat or Steam Sterilization

[00843210167992]

Moist Heat or Steam Sterilization

[00843210167992]

Moist Heat or Steam Sterilization

[00843210167992]

Moist Heat or Steam Sterilization

[00843210167992]

Moist Heat or Steam Sterilization

[00843210167992]

Moist Heat or Steam Sterilization

[00843210167992]

Moist Heat or Steam Sterilization

[00843210167992]

Moist Heat or Steam Sterilization

[00843210167992]

Moist Heat or Steam Sterilization

[00843210167992]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-11
• Device Publish Date: 2024-10-03

On-Brand Devices [Sochi]

• 00843210168555: Screw Offset, Open, 25mm
• 00843210168548: Screw Offset, Closed, 35mm
• 00843210168531: Screw Offset, Closed, 25mm
• 00843210168166: Clamshell Connector, 5.5mm to 5.5mm
• 00843210168159: Wedding Band 5.5mm to 5.5mm Connector
• 00843210168142: Inline Connector, 5.5mm to 5.5mm
• 00843210168135: Screw Offset, Open, 40mm
• 00843210168128: Screw Offset, Open, 30mm
• 00843210168111: Screw Offset, Open, 20mm
• 00843210168104: Screw Offset, Closed, 40mm
• 00843210168098: Screw Offset, Closed, 30mm
• 00843210168081: Screw Offset, Closed, 20mm
• 00843210167862: Self Tapping Occipital Screw, 4.5mm x 12mm
• 00843210167855: Self Tapping Occipital Screw, 4.5mm x 11mm
• 00843210166582: Polyaxial Screw, 4.0mm x 8mm
• 00843210166575: Polyaxial Screw, 3.5mm x 50mm
• 00843210166568: Polyaxial Screw, 3.5mm x 45mm
• 00843210166551: Polyaxial Screw, 3.5mm x 40mm
• 00843210166544: Polyaxial Screw, 3.5mm x 35mm
• 00843210166537: Polyaxial Screw, 3.5mm x 30mm
• 00843210166520: Polyaxial Screw, 3.5mm x 28mm
• 00843210166513: Polyaxial Screw, 3.5mm x 26mm
• 00843210166506: Polyaxial Screw, 3.5mm x 24mm
• 00843210166490: Polyaxial Screw, 3.5mm x 22mm
• 00843210166476: Polyaxial Screw,3.5mm x 18mm
• 00843210166469: Polyaxial Screw, 3.5mm x 16mm
• 00843210166452: Polyaxial Screw, 3.5mm x 14mm
• 00843210166445: Polyaxial Screw, 3.5mm x 12mm
• 00843210166346: Standard Screw, 4.0mm x 14mm
• 00843210166339: Standard Screw, 4.0mm x 12mm
• 00843210166322: Standard Screw, 4.0mm x 10mm
• 00843210166315: Standard Screw, 4.0mm x 8mm
• 00843210166308: Standard Screw, 3.5mm x 28mm
• 00843210166292: Standard Screw, 3.5mm x 26mm
• 00843210166285: Standard Screw,3.5mm x 24mm
• 00843210166278: Standard Screw, 3.5mm x 22mm
• 00843210166261: Standard Screw, 3.5mm x 20mm
• 00843210166254: Standard Screw, 3.5mm x 18mm
• 00843210166247: Standard Screw, 3.5mm x 16mm
• 00843210166230: Standard Screw, 3.5mm x 14mm
• 00843210166223: Standard Screw, 3.5mm x 12mm
• 00843210166216: Standard Screw, 3.5mm x 10mm
• 00843210166209: Standard Screw, 3.5mm x 8mm
• 00843210174280: Polyaxial Screw, 5.0mm x 15mm
• 00843210174273: Polyaxial Screw, 4.5mm x 25mm
• 00843210174266: Polyaxial Screw, 4.5mm x 15mm
• 00843210174242: Polyaxial Screw, 5.0mm x 50mm
• 00843210174235: Polyaxial Screw, 5.0mm x 45mm
• 00843210174228: Polyaxial Screw, 5.0mm x 40mm
• 00843210174211: Polyaxial Screw, 5.0mm x 35mm