StealthStation S8 Spine

GUDID 00763000377939

SFW KIT 9735919 S8 SPINE PLAN STATION

MEDTRONIC NAVIGATION, INC.

Orthopaedic stereotactic surgery system

• Primary Device ID: 00763000377939
• NIH Device Record Key: d91fed00-e909-41a4-b6ce-247f10cab9e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StealthStation S8 Spine
• Version Model Number: 9735919
• Company DUNS: 835233107
• Company Name: MEDTRONIC NAVIGATION, INC.
• 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: false
• Lot Batch: true
• 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

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000377939 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201189

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-31
• Device Publish Date: 2020-08-21

On-Brand Devices [StealthStation S8 Spine]

• 00643169931336: SFW KIT 9735919 S8 SPINE PLAN STATION
• 00643169838994: SW KIT 9735740 STEALTH S8 SPINE
• 00763000125059: SFW KIT 9735919 S8 SPINE PLAN STATION
• 00763000125011: SFW KIT 9735740 STEALTH S8 SPINE
• 00763000076214: SFW KIT 9735919 S8 SPINE PLAN STAT EU-E
• 00763000076122: SFW KIT 9735740 STEALTH S8 SPINE EU-SC
• 00763000076115: SFW KIT 9735740 STEALTH S8 SPINE EU-SE
• 00763000076108: SFW KIT 9735740 STEALTH S8 SPINE EU-E
• 00763000076092: SFW KIT 9735740 STEALTH S8 SPINE EU-SD
• 00763000076085: SFW KIT 9735740 STEALTH S8 SPINE EU-SW
• 00763000076078: SFW KIT 9735740 STEALTH S8 SPINE EU-NW
• 00763000075842: SFW KIT 9735919 S8 SPINE PLAN STAT EU-SC
• 00763000075835: SFW KIT 9735919 S8 SPINE PLAN STAT EU-SD
• 00763000075828: SFW KIT 9735919 S8 SPINE PLAN STAT EU-SE
• 00763000075811: SFW KIT 9735919 S8 SPINE PLAN STAT EU-SW
• 00763000075804: SFW KIT 9735919 S8 SPINE PLAN STAT EU-NW
• 00763000075200: SFW KIT 9735919 S8 SPINE PLAN STATION
• 00763000075149: SFW KIT 9735740 STEALTH S8 SPINE
• 00763000242855: SFW KIT 9735919 S8 SPINE PLAN STATION
• 00763000242923: SFW KIT 9735740 STEALTH S8 SPINE
• 00763000378240: SFW KIT 9735740 STEALTH S8 SPINE
• 00763000377939: SFW KIT 9735919 S8 SPINE PLAN STATION