Jazz System
Tensioner Gen. II - 135° Low Profile Stem
1manufacturer
118catalogue numbers in this listing
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
Record
| Listed by | Implanet, France |
|---|---|
| FDA product code | OWI |
| Device type | Bone Fixation Cerclage, Sublaminar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3010 |
| Establishment | Manufacturer |
| 510(k) | K151740 |
| Record published | 2015-09-24 |
| Record revised | 2021-04-21 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Angle 90 to 135 °; lumen/inner diameter 3.5 to 70 mm; length 15 to 70 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Snapping Forceps | In distribution | |
| JAZZ Claw – Connector | In distribution | |
| JAZZ Claw → Hook Left Large | In distribution | |
| Round Passer → Angled | In distribution | |
| JAZZ Evo → 5mm Connector Kit | In distribution | |
| Tensioner Gen. II – Universal 120° Stem | Angle 120 ° | In distribution |
| Connector Kit | Lumen/Inner Diameter 3.5 mm | In distribution |
| JAZZ → 5.5mm Connector Kit | In distribution | |
| JAZZ Claw → Hook Right | In distribution | |
| Connector Kit | Lumen/Inner Diameter 4.75 mm | In distribution |
| JAZZ – Snapping Forceps – 3,5-4mm | In distribution | |
| Connector Screw | In distribution | |
| Straight Passer → 25mm | Length 25 mm | In distribution |
| Multi-purpose spinal connector | In distribution | |
| JAZZ Claw → Pre-bent Rod Dia. 4/5.5 L70 | In distribution | |
| JAZZ PF 5.5mm/JAZZ band Set | In distribution | |
| Round Passer | In distribution | |
| JAZZ → Open Braid V2 | In distribution | |
| Screw Holder | In distribution | |
| JAZZ Claw-Hook Trial Left | In distribution | |
| Straight Passer-30mm | In distribution | |
| Straight Passer → 15mm | Length 15 mm | In distribution |
| JAZZ CLAW → Instruments Container – Basis | In distribution | |
| JAZZ Band | In distribution | |
| JAZZ CLAW-Hook Trial Right | In distribution | |
| Tensioner Gen.II -Stem 3.5-4mm | In distribution | |
| Forceps | In distribution | |
| JAZZ → 4mm Connector Kit | In distribution | |
| JAZZ Evo → 6mm Connector Kit | In distribution | |
| JAZZ – Snapping Forceps – 3.5-4mm | In distribution | |
| JAZZ Frame → T-Bar – Dia. 5.5/6.0 → L35 | In distribution | |
| JAZZ Claw → Hook Right | In distribution | |
| Tensioner Gen. II – Universal 90° Stem | Angle 90 ° | In distribution |
| JAZZ → 6mm Connector Kit | In distribution | |
| JAZZ Band | In distribution | |
| JAZZ PF – 5,5mm Connector Kit | In distribution | |
| Tensioner Gen. II – 120° Stem | Angle 120 ° | In distribution |
| JAZZ CLAW → Instruments Container – Lid | In distribution | |
| Tensioner Gen.II -Stem 3,5-4mm | In distribution | |
| JAZZ Evo → 6mm Connector Kit | In distribution | |
| JAZZ Claw → Hook Left Large | In distribution | |
| JAZZ Frame → T-Bar – Dia. 5.5/6.0 → L25 | In distribution | |
| JAZZClaw → Hook Right Large | In distribution | |
| JAZZ CLAW -Hook Trial Large Left | In distribution | |
| Tensioner Generation II | In distribution | |
| Large Round Passer | In distribution | |
| JAZZ Evo → 5.5mm Connector Kit | In distribution | |
| JAZZ CLAW-Hook Trial Left | In distribution | |
| Straight Passer → 25mm | In distribution | |
| JAZZ PF 6mm/JAZZ band Set | In distribution | |
| JAZZ Evo → 5mm Connector Kit | In distribution | |
| Connector without braid | In distribution | |
| JAZZ Claw → Pre-bent Rod Dia. 4/5.5 L70 | Length 70 mm | In distribution |
| Tensioner Gen. II – 90° Stem | Angle 90 ° | In distribution |
| Tensioner Gen. II – Winch | In distribution | |
| JAZZ Claw-Hook Trial Large Right | In distribution | |
| JAZZ Claw- Anti-torque Wrench | In distribution | |
| JAZZ PF 6mm/JAZZ Passer band Set | In distribution | |
| Connector Kit | Lumen/Inner Diameter 4.5 mm | In distribution |
| JAZZClaw → Hook Right Large | In distribution | |
| JAZZ Claw → Pre-bent Rod Dia. 4/5.5 L70 – CoCr | In distribution | |
| Universal 120 Degree Stem | In distribution | |
| JAZZ Claw → Straight Rod Dia. 4/5.5 L70 – CoCr | In distribution | |
| Tensioner Gen. II | In distribution | |
| Tensioner Gen. II – Ratchet | In distribution | |
| Tensioner Gen. II → Mobile Capstan | In distribution | |
| Blocker Screwdriver | In distribution | |
| Straight Passer → 20mm | Length 20 mm | In distribution |
| 120 Degree Stem | In distribution | |
| JAZZ Claw – Implant Holder Hook / Blocker | In distribution | |
| JAZZ Claw → Hook Left | In distribution | |
| Universal Snapping Forceps | In distribution | |
| Open braid | In distribution | |
| Straight Passer → 20mm | In distribution | |
| Round Passer → Angled | In distribution | |
| Large Round Passer | In distribution | |
| JAZZ → 4.5mm Connector Kit | In distribution | |
| JAZZ Claw → Straight Rod Dia. 4/5.5 L70 | Lumen/Inner Diameter 70 mm | In distribution |
| JAZZ PF – 6mm Connector Kit | In distribution | |
| JAZZ Evo → 6.35mm Connector Kit | In distribution | |
| JAZZ PF 5.5mm/JAZZ Passer band Set | In distribution | |
| Tensioner Gen. II – 135° Stem | Angle 135 ° | In distribution |
| Universal Stem 90 Degree | In distribution | |
| JAZZ Claw → Hook Left | In distribution | |
| JAZZ → 4.75mm Connector Kit | In distribution | |
| JAZZ CLAW-Hook Trial Large Right | In distribution | |
| Cap SP Tensioner Stem | In distribution | |
| Tensioner Gen. II – 135° Low Profile Stem | Angle 135 ° | In distribution |
| JAZZ Claw-Hook Trial Right | In distribution | |
| JAZZ Claw → Straight Rod Dia. 4/5.5 L70 | In distribution | |
| JAZZ Claw -Hook Trial Large Left | In distribution | |
| Braid Puller Forceps | In distribution | |
| Braid Forceps | In distribution | |
| JAZZ CLAW – Implant Holder Hook / Blocker | In distribution | |
| Straight Passer → 15mm | In distribution | |
| Connector Kit | Lumen/Inner Diameter 5.5 mm | In distribution |
| Connector Kit | Lumen/Inner Diameter 6.35 mm | In distribution |
| JAZZ Evo → 5.5mm Connector Kit | In distribution | |
| Straight Passer-30mm | In distribution | |
| Tensioner Gen. II – Universal 135° Stem | Angle 135 ° | In distribution |
| Universal Snapping Forceps | In distribution | |
| Puller Forceps | In distribution | |
| Tensioner Gen. II – 120° Low Profile Stem | Angle 120 ° | In distribution |
| Universal 120° Stem Short | In distribution | |
| JAZZ – 3.5mm Connector Kit | In distribution | |
| Round Passer | In distribution | |
| Tensioner Gen. II – 90° Low Profile Stem | Angle 90 ° | In distribution |
| JAZZ Claw → Pre-bent Rod Dia. 4/5.5 L70 – CoCr | Length 70 mm | In distribution |
| Connector Kit | Lumen/Inner Diameter 6 mm | In distribution |
| JAZZ PF Band Reducer | In distribution | |
| JAZZ Claw → Straight Rod Dia. 4/5.5 L70 – CoCr | Length 70 mm | In distribution |
| JAZZ Passer Band | In distribution | |
| Connector Kit | Lumen/Inner Diameter 4 mm | In distribution |
| Tensioner | In distribution | |
| Round passer R20 | In distribution | |
| JAZZ Passer Band | In distribution | |
| JAZZ Claw – Connector | In distribution | |
| JAZZ Frame → T-Bar – Dia. 5.5/6.0 → L30 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hiline | Globus Medical, Inc. | 22 |
| Ligapass | Medicrea International | 20 |
| Translace™ Spinal Tethering System | Medtronic Sofamor Danek, Inc. | 14 |
| Nile™ Alternative Fixation System | VB Spine LLC | 13 |
| Nile™ Proximal Fixation System | VB Spine LLC | 13 |
| Universal Clamp ™ | Zimmer Spine, Inc. | 9 |
| VersaTie | Nuvasive, Inc. | 8 |
| Silc | Globus Medical, Inc. | 8 |
| Mariner Cap | Seaspine Orthopedics Corporation | 7 |
| Jazz Lock | Implanet | 6 |
| Invictus | Alphatec Spine, Inc. | 5 |
| Karma | Spinal Elements, Inc. | 3 |
Showing 12 of 20. All products under Bone Fixation Cerclage, Sublaminar
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.