neon³™ OCT spinal stabilization CS 3950-07

GUDID 04052536176694

OC drillguide for screws, length 14 and 16 mm, drill depth 16 and 18 mm

Ulrich GmbH & Co. KG

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 04052536176694
• NIH Device Record Key: 89122f42-5835-44ae-9ef9-722d6b7cc135
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neon³™ OCT spinal stabilization
• Version Model Number: CS 3950-07
• Catalog Number: CS 3950-07
• Company DUNS: 315494757
• Company Name: Ulrich GmbH & Co. KG
• 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: +4907319654152
• Email: safety@ulrichmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536176694 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161032

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[04052536176694]

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: 2018-02-14

On-Brand Devices [neon³™ OCT spinal stabilization]

• 04052536176694: OC drillguide for screws, length 14 and 16 mm, drill depth 16 and 18 mm
• 04052536176687: OC drillguide for screws, length 10 and 12 mm, drill depth 12 and 14 mm
• 04052536176670: OC drillguide for screws, length 6 and 8 mm, drill depth 8 and 10 mm
• 04052536169375: Locking screw for crosslink, screw-to-screw
• 04052536169344: Locking screw with adapter for crosslink, screw-to-screw
• 04052536168507: Crosslink, rod-to-rod, small, L, length 44 - 59 mm
• 04052536168491: Crosslink, rod-to-rod, small, M, length 39 - 49 mm
• 04052536168484: Crosslink, rod-to-rod, small, S, length 34 - 44 mm
• 04052536168477: OC-rod, titanium alloy, Ø 4.0 mm, 90° curved, length 300 mm (100 / 200 mm)
• 04052536161621: Crosslink, screw to screw, L
• 04052536161614: Crosslink, screw to screw, M
• 04052536161607: Crosslink, screw to screw, S
• 04052536161560: Counter hook, long, for atlas claw, Ø 4.0 mm
• 04052536161539: OC rod, titanium alloy, Ø 4.0 mm, straight, length 240 mm, screw hole
• 04052536161522: OC rod, titanium alloy, Ø 4.0 mm, straight, length 240 mm, long hole
• 04052536161508: OC rod, hinged, titanium alloy, Ø 4.0 mm
• 04052536161492: Occipital plate, midline, 57 mm, for rod, Ø 4.0 mm
• 04052536161485: Occipital plate, midline, 47 mm, for rod, Ø 4.0 mm
• 04052536161478: Occipital plate, midline, 57 mm, for OC rod
• 04052536161461: Occipital plate, midline, 47 mm, for OC rod
• 04052536161454: Occipital plate, lateral, with rod
• 04052536114047: Occipital screw, Ø 5.0 mm, length 16 mm, self-tapping
• 04052536114030: Occipital screw, Ø 5.0 mm, length 14 mm, self-tapping
• 04052536114023: Occipital screw, Ø 5.0 mm, length 12 mm, self-tapping
• 04052536114016: Occipital screw, Ø 5.0 mm, length 10 mm, self-tapping
• 04052536114009: Occipital screw, Ø 5.0 mm, length 8 mm, self-tapping
• 04052536113996: Occipital screw, Ø 5.0 mm, length 6 mm, self-tapping
• 04052536085026: Counter hook for atlas claw, Ø 4.0 mm
• 04052536085019: Rod, for atlas claw, Ø 4.0 mm
• 04052536084906: OC locking screw
• 04052536084852: Rod, CoCr, Ø 4.0 mm, length 400 mm, with hex end