Silverstone Titanium Interbody Fusion System

GUDID B417SP301011T1

30L PLIF Titanium Silverstone-P

Altus Spine, LLC

Metallic spinal fusion cage, non-sterile

• Primary Device ID: B417SP301011T1
• NIH Device Record Key: 1f9cf800-ad33-4dcb-99d2-431be66d6ab9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silverstone Titanium Interbody Fusion System
• Version Model Number: SP301011T
• 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: +1(610)355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)355-4156
• Email: Info@altus-spine.com

Device Dimensions

• Height: 11 Millimeter
• Angle: 7 degree
• Length: 30 Millimeter
• Width: 10 Millimeter
• Height: 11 Millimeter
• Angle: 7 degree
• Length: 30 Millimeter
• Width: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843210106540 [Secondary]
HIBCC	B417SP301011T1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170512

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[B417SP301011T1]

Moist Heat or Steam Sterilization

[B417SP301011T1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-22

On-Brand Devices [Silverstone Titanium Interbody Fusion System]

• B417ST83216T21: 8degree TLIF Titanium Silverstone-T
• B417ST83216T1: 8degree TLIF Titanium Silverstone-T
• B417ST83215T21: 8degree TLIF Titanium Silverstone-T
• B417ST83215T1: 8degree TLIF Titanium Silverstone-T
• B417ST83214T21: 8degree TLIF Titanium Silverstone-T
• B417ST83214T1: 8degree TLIF Titanium Silverstone-T
• B417ST83213T21: 8degree TLIF Titanium Silverstone-T
• B417ST83213T1: 8degree TLIF Titanium Silverstone-T
• B417ST83212T21: 8degree TLIF Titanium Silverstone-T
• B417ST83212T1: 8degree TLIF Titanium Silverstone-T
• B417ST83211T21: 8degree TLIF Titanium Silverstone-T
• B417ST83211T1: 8degree TLIF Titanium Silverstone-T
• B417ST83210T21: 8degree TLIF Titanium Silverstone-T
• B417ST83210T1: 8degree TLIF Titanium Silverstone-T
• B417ST83209T21: 8degree TLIF Titanium Silverstone-T
• B417ST83209T1: 8degree TLIF Titanium Silverstone-T
• B417ST83208T21: 8degree TLIF Titanium Silverstone-T
• B417ST83208T1: 8degree TLIF Titanium Silverstone-T
• B417ST83207T21: 8degree TLIF Titanium Silverstone-T
• B417ST83207T1: 8degree TLIF Titanium Silverstone-T
• B417ST83206T21: 8degree TLIF Titanium Silverstone-T
• B417ST83206T1: 8degree TLIF Titanium Silverstone-T
• B417ST82816T21: 8degree TLIF Titanium Silverstone-T
• B417ST82816T1: 8degree TLIF Titanium Silverstone-T
• B417ST82815T21: 8degree TLIF Titanium Silverstone-T
• B417ST82815T1: 8degree TLIF Titanium Silverstone-T
• B417ST82814T21: 8degree TLIF Titanium Silverstone-T
• B417ST82814T1: 8degree TLIF Titanium Silverstone-T
• B417ST82813T21: 8degree TLIF Titanium Silverstone-T
• B417ST82813T1: 8degree TLIF Titanium Silverstone-T
• B417ST82812T21: 8degree TLIF Titanium Silverstone-T
• B417ST82812T1: 8degree TLIF Titanium Silverstone-T
• B417ST82811T21: 8degree TLIF Titanium Silverstone-T
• B417ST82811T1: 8degree TLIF Titanium Silverstone-T
• B417ST82810T21: 8degree TLIF Titanium Silverstone-T
• B417ST82810T1: 8degree TLIF Titanium Silverstone-T
• B417ST82809T21: 8degree TLIF Titanium Silverstone-T
• B417ST82809T1: 8degree TLIF Titanium Silverstone-T
• B417ST82808T21: 8degree TLIF Titanium Silverstone-T
• B417ST82808T1: 8degree TLIF Titanium Silverstone-T
• B417ST82807T21: 8degree TLIF Titanium Silverstone-T
• B417ST82807T1: 8degree TLIF Titanium Silverstone-T
• B417ST82806T21: 8degree TLIF Titanium Silverstone-T
• B417ST82806T1: 8degree TLIF Titanium Silverstone-T
• B417ST82216T21: 8degree TLIF Titanium Silverstone-T
• B417ST82216T1: 8degree TLIF Titanium Silverstone-T
• B417ST82215T21: 8degree TLIF Titanium Silverstone-T
• B417ST82215T1: 8degree TLIF Titanium Silverstone-T
• B417ST82214T21: 8degree TLIF Titanium Silverstone-T
• B417ST82214T1: 8degree TLIF Titanium Silverstone-T