flamenco™ spinal fixation system CS 8013-060

GUDID 04052536021642

flamenco crosslink, length 60 mm, consisting of: CS 8013-01-060, -02 (2x), -03 (2x)

Ulrich GmbH & Co. KG

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 04052536021642
• NIH Device Record Key: 19da60fc-dba0-48e4-9b92-9fd1a7ddb944
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: flamenco™ spinal fixation system
• Version Model Number: CS 8013-060
• Catalog Number: CS 8013-060
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536021642 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102853

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[04052536021642]

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 [flamenco™ spinal fixation system]

• 04052536114313: flamenco screw, polyaxial, light blue, Ø 4.5 mm, length 55 mm
• 04052536114306: flamenco rod, Ø 5.5 mm, length 100 mm, pre-bent
• 04052536114290: flamenco rod, Ø 5.5 mm, length 90 mm, pre-bent
• 04052536114283: flamenco rod, Ø 5.5 mm, length 80 mm, pre-bent
• 04052536114276: flamenco rod, Ø 5.5 mm, length 70 mm, pre-bent
• 04052536114269: flamenco rod, Ø 5.5 mm, length 60 mm, pre-bent
• 04052536114252: flamenco rod, Ø 5.5 mm, length 50 mm, pre-bent
• 04052536114245: flamenco rod, Ø 5.5 mm, length 40 mm, pre-bent
• 04052536087792: flamenco locking screw, bronze, for screw-Ø 8.0 mm
• 04052536087785: flamenco screw, long-arm, polyaxial, bronze, Ø 8.0 mm, length 60 mm
• 04052536087778: flamenco screw, long-arm, polyaxial, bronze, Ø 8.0 mm, length 55 mm
• 04052536087761: flamenco screw, long-arm, polyaxial, bronze, Ø 8.0 mm, length 50 mm
• 04052536087754: flamenco screw, long-arm, polyaxial, bronze, Ø 8.0 mm, length 45 mm
• 04052536087747: flamenco screw, long-arm, polyaxial, bronze, Ø 8.0 mm, length 40 mm
• 04052536087730: flamenco screw, long-arm, polyaxial, bronze, Ø 8.0 mm, length 35 mm
• 04052536087723: flamenco screw, long-arm, polyaxial, green, Ø 6.5 mm, length 55 mm
• 04052536087716: flamenco screw, long-arm, polyaxial, green, Ø 6.5 mm, length 50 mm
• 04052536087709: flamenco screw, long-arm, polyaxial, green, Ø 6.5 mm, length 45 mm
• 04052536087693: flamenco screw, long-arm, polyaxial, green, Ø 6.5 mm, length 40 mm
• 04052536087686: flamenco screw, long-arm, polyaxial, green, Ø 6.5 mm, length 35 mm
• 04052536087679: flamenco screw, long-arm, polyaxial, green, Ø 6.5 mm, length 30 mm
• 04052536087662: flamenco screw, long-arm, polyaxial, yellow, Ø 5.5 mm, length 50 mm
• 04052536087655: flamenco screw, long-arm, polyaxial, yellow, Ø 5.5 mm, length 45 mm
• 04052536087648: flamenco screw, long-arm, polyaxial, yellow, Ø 5.5 mm, length 40 mm
• 04052536087631: flamenco screw, long-arm, polyaxial, yellow, Ø 5.5 mm, length 35 mm
• 04052536087624: flamenco screw, long-arm, polyaxial, yellow, Ø 5.5 mm, length 30 mm
• 04052536087617: flamenco screw, long-arm, monoaxial, blue, Ø 7.5 mm, length 55 mm
• 04052536087600: flamenco screw, long-arm, monoaxial, blue, Ø 7.5 mm, length 50 mm
• 04052536087594: flamenco screw, long-arm, monoaxial, blue, Ø 7.5 mm, length 45 mm
• 04052536087587: flamenco screw, long-arm, monoaxial, blue, Ø 7.5 mm, length 40 mm
• 04052536087570: flamenco screw, long-arm, monoaxial, blue, Ø 7.5 mm, length 35 mm
• 04052536087471: flamenco screw, polyaxial, bronze, Ø 8.0 mm, length 55 mm
• 04052536087464: flamenco screw, polyaxial, bronze, Ø 8.0 mm, length 50 mm
• 04052536087457: flamenco screw, polyaxial, bronze, Ø 8.0 mm, length 45 mm
• 04052536087440: flamenco screw, polyaxial, bronze, Ø 8.0 mm, length 40 mm
• 04052536087433: flamenco screw, polyaxial, bronze, Ø 8.0 mm, length 35 mm
• 04052536087389: flamenco screw, polyaxial, light blue, Ø 4.5 mm, length 50 mm
• 04052536087372: flamenco screw, polyaxial, light blue, Ø 4.5 mm, length 45 mm
• 04052536087365: flamenco screw, polyaxial, light blue, Ø 4.5 mm, length 40 mm
• 04052536087358: flamenco screw, polyaxial, light blue, Ø 4.5 mm, length 25 mm
• 04052536021819: flamenco offset hook, right, width 7 mm, length 11 mm
• 04052536021802: flamenco offset hook, right, width 7 mm, length 9 mm
• 04052536021789: flamenco rod-rod-connector, axial, ø 5.5 to 5.5 mm
• 04052536021765: flamenco rod-rod-connector, parallel, ø 5.5 to 5.5 mm
• 04052536021758: flamenco offset hook, left, width 7 mm, length 11 mm
• 04052536021741: flamenco offset hook, left, width 7 mm, length 9 mm
• 04052536021734: flamenco lamina hook, width 7 mm, length 9 mm
• 04052536021727: flamenco lamina hook, width 7 mm, length 7 mm
• 04052536021710: flamenco lamina hook, width 5 mm, length 9 mm
• 04052536021703: flamenco lamina hook, width 5 mm, length 7 mm