neon™ superior spine system CS 1401-38T

GUDID 04052536002900

neon screw, self-tapping, cannulated, Ø 4.0 mm, length 38 mm

Ulrich GmbH & Co. KG

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 04052536002900
• NIH Device Record Key: ec4daef4-56c9-46bc-8876-45d145400e6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neon™ superior spine system
• Version Model Number: CS 1401-38T
• Catalog Number: CS 1401-38T
• Company DUNS: 315494757
• Company Name: Ulrich GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536002900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113346

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

Moist Heat or Steam Sterilization

[04052536002900]

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: 2016-07-30

On-Brand Devices [neon™ superior spine system]

• 04052536007462: neon locking screw for hook
• 04052536007455: neon hook, curved, left
• 04052536007448: neon hook, curved, right
• 04052536007431: neon hook, straight, long
• 04052536007424: neon hook, straight, short
• 04052536003471: neon locking plate for crosslink
• 04052536003464: neon hook for crosslink
• 04052536003457: neon x-plate for crosslink, length 65 mm
• 04052536003440: neon x-plate for crosslink, length 50 mm
• 04052536003419: neon spacer, green, height 4 mm
• 04052536003402: neon spacer, red, height 2 mm
• 04052536003396: neon hex nut for easy fit, gold
• 04052536003389: neon easy fit, gold
• 04052536003372: neon locking screw for connector length 19 mm
• 04052536003365: neon connector, blue, polyaxial, length 19 mm
• 04052536003358: neon connector, red, polyaxial, length 17 mm
• 04052536003341: neon connector, green, polyaxial, length 15 mm
• 04052536003334: neon inlay for connector, polyaxial
• 04052536003327: neon rod, Ø 4.5 mm, length 95 mm
• 04052536003310: neon rod, Ø 4.5 mm, length 90 mm
• 04052536003303: neon rod, Ø 4.5 mm, length 85 mm
• 04052536003297: neon rod, Ø 4.5 mm, length 80 mm
• 04052536003280: neon rod, Ø 4.5 mm, length 75 mm
• 04052536003273: neon rod, Ø 4.5 mm, length 70 mm
• 04052536003266: neon rod, Ø 4.5 mm, length 65 mm
• 04052536003259: neon rod, Ø 4.5 mm, length 60 mm
• 04052536003242: neon rod, Ø 4.5 mm, length 55 mm
• 04052536003235: neon rod, Ø 4.5 mm, length 50 mm
• 04052536003228: neon rod, Ø 4.5 mm, length 45 mm
• 04052536003211: neon rod, Ø 4.5 mm, length 40 mm
• 04052536003204: neon rod, Ø 4.5 mm, length 35 mm
• 04052536003198: neon rod, Ø 4.5 mm, length 30 mm
• 04052536003181: neon rod, Ø 4.5 mm, length 25 mm
• 04052536003174: neon rod, Ø 4.5 mm, length 230 mm
• 04052536003167: neon rod, Ø 4.5 mm, length 20 mm
• 04052536003150: neon rod, Ø 4.5 mm, length 200 mm
• 04052536003143: neon rod, Ø 4.5 mm, length 160 mm
• 04052536003136: neon rod, Ø 4.5 mm, length 140 mm
• 04052536003129: neon rod, Ø 4.5 mm, length 120 mm
• 04052536003112: neon rod, Ø 4.5 mm, length 100 mm
• 04052536003105: neon OC rod
• 04052536003099: neon M plate for OC-stabilization
• 04052536003082: neon cortical bone screw, Ø 3.5 mm, length 8 mm
• 04052536003075: neon cortical bone screw, Ø 3.5 mm, length 18 mm
• 04052536003068: neon cortical bone screw, Ø 3.5 mm, length 16 mm
• 04052536003051: neon cortical bone screw, Ø 3.5 mm, length 14 mm
• 04052536003044: neon cortical bone screw, Ø 3.5 mm, length 12 mm
• 04052536003037: neon cortical bone screw, Ø 3.5 mm, length 10 mm
• 04052536003020: neon screw, self-tapping, cannulated, Ø 5.0 mm, length 50 mm
• 04052536003013: neon screw, self-tapping, cannulated, Ø 5.0 mm, length 45 mm