JAZZ System 360723

GUDID 10889981188269

IMPLANET

Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 10889981188269
• NIH Device Record Key: 7a2f60d4-bf1a-4c94-9420-5c727b6c28ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JAZZ System
• Version Model Number: JAZZ Frame – T-Bar - Dia. 5.5/6.0 – L35
• Catalog Number: 360723
• Company DUNS: 291993439
• Company Name: IMPLANET
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981188269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191217

FDA Product Code

• OWI: Bone Fixation Cerclage, Sublaminar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-22
• Device Publish Date: 2020-09-14

On-Brand Devices [JAZZ System]

• 03607505503516: Round passer R20
• 03607505503509: Straight Passer-30mm
• 03607505500621: Cap SP Tensioner Stem
• 03607503502603: JAZZ Evo – 6mm Connector Kit
• 03607503502580: JAZZ Evo – 5.5mm Connector Kit
• 03607503502566: JAZZ Evo – 5mm Connector Kit
• 03607503501576: JAZZ Passer Band
• 03607505504032: Hexagonal 3,5 Evo Screwdriver
• 03607505504025: JAZZ CLAW – Instruments Container - Lid
• 03607505504018: JAZZ CLAW – Instruments Container - Basis
• 03607505500638: Cap SP anti-torque wrench
• 03607505502953: Tensioner Gen. II
• 03607505500591: Snapping Forceps
• 03607505500577: Forceps
• 03607505500560: Tensioner
• 03607503507189: Pre-bent Rod Dia. 4/5.5 L70 - CoCr
• 03607503507172: Pre-bent Rod Dia. 4/5.5 L70
• 03607503507165: Straight Rod Dia. 4/5.5 L70 - CoCr
• 03607503507158: Straight Rod Dia. 4/5.5 L70
• 03607503507141: Hook Left Large
• 03607503507134: Hook Right Large
• 03607503507127: Hook Left
• 03607503507110: Hook Right
• 03607503507103: Connector
• 03607503506946: JAZZ Cap SP, H14
• 03607503506922: JAZZ Cap SP, H12
• 03607503506908: JAZZ Cap SP, H10
• 03607503506885: Jazz Rod - Straight Union Rod Dia.6.0 L400
• 03607503506878: Jazz Rod - Straight Union Rod Dia.6.0 L300
• 03607503506861: Jazz Rod - Straight Union Rod Dia.6.0 L200
• 03607503506854: Jazz Rod - Straight Union Rod Dia.6.0 L160
• 03607503506847: Jazz Rod - Straight Union Rod Dia.6.0 L120
• 03607503506830: Jazz Rod - Straight Union Rod Dia.6.0 L110
• 03607503506823: Jazz Rod - Pre-bent Union Rod Dia.6.0 L100
• 03607503506816: Jazz Rod - Pre-bent Union Rod Dia.6.0 L90
• 03607503506809: Jazz Rod - Pre-bent Union Rod Dia.6.0 L80
• 03607503506793: Jazz Rod - Pre-bent Union Rod Dia.6.0 L70
• 03607503506786: Jazz Rod - Pre-bent Union Rod Dia.6.0 L60
• 03607503506779: Jazz Rod - Pre-bent Union Rod Dia.6.0 L50
• 03607503506762: Jazz Rod - Pre-bent Union Rod Dia.6.0 L40
• 03607503506755: Jazz Rod - Pre-bent Union Rod Dia.6.0 L30
• 03607503506731: Jazz Rod - Straight Union Rod – L400
• 03607503506724: Jazz Rod - Straight Union Rod – L300
• 03607503506717: Jazz Rod - Straight Union Rod – L200
• 03607503506700: Jazz Rod - Straight Union Rod – L160
• 03607503506694: Jazz Rod - Straight Union Rod – L120
• 03607503506687: Jazz Rod - Straight Union Rod – L110
• 03607503506670: Jazz Rod - Pre-bent Union Rod – L100
• 03607503506663: Jazz Rod - Pre-bent Union Rod – L90
• 03607503506656: Jazz Rod - Pre-bent Union Rod – L80