JAZZ System 550407

GUDID 03607505504070

IMPLANET

Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner

• Primary Device ID: 03607505504070
• NIH Device Record Key: 14ba74df-f30b-4d78-a67d-be01b659b621
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JAZZ System
• Version Model Number: Tensioner Gen.II -Stem 3.5-4mm
• Catalog Number: 550407
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607505504070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191217

FDA Product Code

• OWI: Bone Fixation Cerclage, Sublaminar

Sterilization

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

[03607505504070]

Moist Heat or Steam Sterilization

[03607505504070]

Moist Heat or Steam Sterilization

[03607505504070]

Moist Heat or Steam Sterilization

[03607505504070]

Moist Heat or Steam Sterilization

[03607505504070]

Moist Heat or Steam Sterilization

[03607505504070]

Moist Heat or Steam Sterilization

[03607505504070]

Moist Heat or Steam Sterilization

[03607505504070]

Moist Heat or Steam Sterilization

[03607505504070]

Moist Heat or Steam Sterilization

[03607505504070]

Moist Heat or Steam Sterilization

[03607505504070]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-13
• Device Publish Date: 2021-05-05

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