STEALTH™ Anterior Cervical Interbody Spacer

GUDID 00840996146500

STEALTH,INSERTER SLEEVE,STOPS,9-12,+1

Choice Spine, LP

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840996146500
• NIH Device Record Key: 2c6a4f00-7917-4b27-a845-2612349ebce1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STEALTH™ Anterior Cervical Interbody Spacer
• Version Model Number: SPCL-DA02
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• 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(865)246-3333
• Email: info@choicespine.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996146500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091531

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00840996146500]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-01-21

On-Brand Devices [STEALTH™ Anterior Cervical Interbody Spacer]

• 00840996146548: STEALTH,INSERTER SLEEVE,STOPS,9-12,+3
• 00840996146531: STEALTH,INSERTER SLEEVE,STOPS,5-8,+3
• 00840996146524: STEALTH,INSERTER SLEEVE,STOPS,9-12,+2
• 00840996146517: STEALTH,INSERTER SLEEVE,STOPS,5-8,+2
• 00840996146500: STEALTH,INSERTER SLEEVE,STOPS,9-12,+1
• 00840996146494: STEALTH,INSERTER SLEEVE,STOPS,5-8,+1
• 00840996146487: STEALTH,INLINE INSERTER
• 00840996130196: STEALTH,TRIAL,NO STOP,14X16X12,6 DEG
• 00840996130189: STEALTH,TRIAL,NO STOP,14X16X11,6 DEG
• 00840996130172: STEALTH,TRIAL,NO STOP,14X16X10,6 DEG
• 00840996130165: STEALTH,TRIAL,NO STOP,14X16X9,6 DEG
• 00840996130158: STEALTH,TRIAL,NO STOP,14X16X8,6 DEG
• 00840996130141: STEALTH,TRIAL,NO STOP,14X16X7,6 DEG
• 00840996130134: STEALTH,TRIAL,NO STOP,14X16X6,6 DEG
• 00840996130127: STEALTH,TRIAL,NO STOP,14X16X5,6 DEG
• 00840996130110: STEALTH,TRIAL,NO STOP,14X16X12,0 DEG
• 00840996130103: STEALTH,TRIAL,NO STOP,14X16X11,0 DEG
• 00840996130097: STEALTH,TRIAL,NO STOP,14X16X10,0 DEG
• 00840996130080: STEALTH,TRIAL,NO STOP,14X16X9,0 DEG
• 00840996130073: STEALTH,TRIAL,NO STOP,14X16X8,0 DEG
• 00840996130066: STEALTH,TRIAL,NO STOP,14X16X7,0 DEG
• 00840996130059: STEALTH,TRIAL,NO STOP,14X16X6,0 DEG
• 00840996130042: STEALTH,TRIAL,NO STOP,14X16X5,0 DEG
• 00840996130035: STEALTH,TRIAL,NO STOP,12X14X12,6 DEG
• 00840996130028: STEALTH,TRIAL,NO STOP,12X14X11,6 DEG
• 00840996130011: STEALTH,TRIAL,NO STOP,12X14X10,6 DEG
• 00840996130004: STEALTH,TRIAL,NO STOP,12X14X9,6 DEG
• 00840996129992: STEALTH,TRIAL,NO STOP,12X14X8,6 DEG
• 00840996129985: STEALTH,TRIAL,NO STOP,12X14X7,6 DEG
• 00840996129978: STEALTH,TRIAL,NO STOP,12X14X6,6 DEG
• 00840996129961: STEALTH,TRIAL,NO STOP,12X14X5,6 DEG
• 00840996129954: STEALTH,TRIAL,NO STOP,12X14X12,0 DEG
• 00840996129947: STEALTH,TRIAL,NO STOP,12X14X11,0 DEG
• 00840996129930: STEALTH,TRIAL,NO STOP,12X14X10,0 DEG
• 00840996129923: STEALTH,TRIAL,NO STOP,12X14X9,0 DEG
• 00840996129916: STEALTH,TRIAL,NO STOP,12X14X8,0 DEG
• 00840996129909: STEALTH,TRIAL,NO STOP,12X14X7,0 DEG
• 00840996129893: STEALTH,TRIAL,NO STOP,12X14X6,0 DEG
• 00840996129886: STEALTH,TRIAL,NO STOP,12X14X5,0 DEG
• 00840996129879: STEALTH,TRIAL RASP,NS,14X16X12,6 DEG
• 00840996129862: STEALTH,TRIAL RASP,NS,14X16X11,6 DEG
• 00840996129855: STEALTH,TRIAL RASP,NS,14X16X10,6 DEG
• 00840996129848: STEALTH,TRIAL RASP,NS,14X16X9,6 DEG
• 00840996129831: STEALTH,TRIAL RASP,NS,14X16X8,6 DEG
• 00840996129824: STEALTH,TRIAL RASP,NS,14X16X7,6 DEG
• 00840996129817: STEALTH,TRIAL RASP,NS,14X16X6,6 DEG
• 00840996129800: STEALTH,TRIAL RASP,NS,14X16X5,6 DEG
• 00840996129794: STEALTH,TRIAL RASP,NS,12X14X12,6 DEG
• 00840996129787: STEALTH,TRIAL RASP,NS,12X14X11,6 DEG
• 00840996129770: STEALTH,TRIAL RASP,NS,12X14X10,6 DEG