SYMPHONY 102041510

GUDID 10705034519302

SYMPHONY OCT SYSTEM OFFSET ROD DUAL DIAMETER TITANIUM ALLOY, LARGE OFFSET diameter 4.0 to 5.5X420mm 4.0

Medos International Sàrl

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10705034519302
• NIH Device Record Key: ff79dd4e-63b1-414a-a139-39d7099035b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYMPHONY
• Version Model Number: 1020-41-510
• Catalog Number: 102041510
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• 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: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034519302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203319

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

[10705034519302]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-19
• Device Publish Date: 2021-02-11

On-Brand Devices [SYMPHONY]

• 10705034538990: SYMPHONY OCT SYSTEM MODULAR CASE SMALL GRAPHIC CASE
• 10705034538983: SYMPHONY OCT SYSTEM MODULAR CASE LARGE GRAPHIC CASE
• 10705034538976: SYMPHONY OCT SYSTEM 3.5mm SCREW CADDY MODULE
• 10705034538969: SYMPHONY OCT SYSTEM 3.5mm CURVED ROD MODULE
• 10705034538952: SYMPHONY OCT SYSTEM CORE IMPLANT TRAY
• 10705034538945: SYMPHONY OCT SYSTEM 3.5mm AND 4.0mm CURVED ROD MODULE
• 10705034537320: SYMPHONY OCT SYSTEM 3.5mm SET SCREW AND CONNECTOR MODULE
• 10705034537313: SYMPHONY OCT SYSTEM 3.5mm AND 4.0mm SET SCREW AND CONNECTOR MODULE
• 10705034537306: SYMPHONY OCT SYSTEM 3.5mm AND 4.0mm SCREW CADDY MODULE
• 10705034536132: SYMPHONY OCT SYSTEM SYNAPS TO SYMPHONY UPGRADE 2 OF 2 GRAPHIC CASE
• 10705034536095: SYMPHONY OCT SYSTEM CORE PLUS INSTRUMENT GRAPHIC CASE
• 10705034536088: SYMPHONY OCT SYSTEM UPGRADE BOOSTER GRAPHIC CASE
• 10705034536064: SYMPHONY OCT SYSTEM CROSS CONNECTOR MODULE
• 10705034536057: SYMPHONY OCT SYSTEM DUAL DIAMETER AND COBALT CHROMIUM ROD MODULE GRAPHIC CASE
• 10705034536002: SYMPHONY OCT SYSTEM SHAFT SCREW FOR 3.5mm AND 4.0mm ROD MODULE
• 10705034535999: SYMPHONY OCT SYSTEM SYNAPSE 3.5 TO SYMPHONY UPGRADE 1 OF 2 GRAPHIC CASE
• 10705034535982: SYMPHONY OCT SYSTEM CORE SYMPHONY 2 OF 2 INSTRUMENT GRAPHIC CASE
• 10705034535975: SYMPHONY OCT SYSTEM CORE SYMPHONY 1 OF 2 IMPLANT AND INSTRUMENT GRAPHIC CASE
• 10705034535968: SYMPHONY OCT SYSTEM SHAFT SCREW FOR 3.5mm ROD ONLY MODULE
• 10705034533230: SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER TISSUE SLEEVE
• 10705034532813: SYMPHONY OCT SYSTEM AO HANDLE, TORQUE LIMITING 3.0Nm
• 10705034532806: SYMPHONY OCT SYSTEM X15 SELF RETAINING SET SCREW INSERTER
• 10705034532790: SYMPHONY OCT SYSTEM X15 DRIVER FINAL TIGHTENER
• 10705034532776: SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER RETENTION SLEEVE
• 10705034532769: SYMPHONY OCT SYSTEM NUT DRIVER SELF RETAINING
• 10705034532639: SYMPHONY OCT SYSTEM AO HANDLE, T-STYLE WITH RATCHET
• 10705034532622: SYMPHONY OCT SYSTEM AO HANDLE, SMALL WITH SWIVEL
• 10705034532615: SYMPHONY OCT SYSTEM AO HANDLE, MEDIUM WITH RATCHET
• 10705034532592: SYMPHONY OCT SYSTEM DUAL SIDED SET SCREW INSERTER
• 10705034532578: SYMPHONY OCT SYSTEM TAP, STANDARD THREADS 3.5mm 0-50mm +/-0.75 percent
• 10705034532554: SYMPHONY OCT SYSTEM TAP, STANDARD THREADS 3.0mm 0-50mm +/-0.75 percent
• 10705034531892: SYMPHONY OCT SYSTEM TAP, STANDARD THREADS 4.5mm 0-50mm +/-0.75 percent
• 10705034531885: SYMPHONY OCT SYSTEM TAP, STANDARD THREADS 4.0mm 0-50mm +/-0.75 percent
• 10705034531830: SYMPHONY OCT SYSTEM LONG DRILL BIT FOR 4.5mm SCREWS 3.2mm
• 10705034531823: SYMPHONY OCT SYSTEM LONG DRILL BIT FOR 4.0mm SCREWS 2.8mm
• 10705034531816: SYMPHONY OCT SYSTEM LONG DRILL BIT FOR 3.0mm SCREWS 2.2mm
• 10705034531045: SYMPHONY OCT SYSTEM ROD TO ROD CROSSCONNECTOR COUNTER TORQUE
• 10705034531021: SYMPHONY OCT SYSTEM PEDICLE PROBE, STRAIGHT 3.2mm 0-50mm +/- 2 percent
• 10705034530994: SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER SHAFT X20
• 10705034530949: SYMPHONY OCT SYSTEM TAP, CORTICAL FIX THREADS 5.5mm
• 10705034530925: SYMPHONY OCT SYSTEM TAP, CORTICAL FIX THREADS 5.0mm
• 10705034530895: SYMPHONY OCT SYSTEM TAP, CORTICAL FIX THREADS 4.5mm
• 10705034530864: SYMPHONY OCT SYSTEM TAP, CORTICAL FIX THREADS 4.0mm
• 10705034530710: SYMPHONY OCT SYSTEM LONG DRILL BIT FOR 3.5mm SCREWS 2.4mm
• 10705034530680: SYMPHONY OCT SYSTEM PEDICLE PROBE, CURVED 3.2mm 0-50mm +/- 2 percent
• 10705034530659: SYMPHONY OCT SYSTEM DRILL BIT FOR 4.0mm SCREW, FOR SYNAPSE DRILL GUIDE 2.8mm
• 10705034530604: SYMPHONY OCT SYSTEM BENDING IRON LEFT
• 10705034530598: SYMPHONY OCT SYSTEM BENDING IRON RIGHT
• 10705034530581: SYMPHONY OCT SYSTEM FRENCH ROD BENDER FOR 3.5mm AND 4.0mm RODS
• 10705034530567: SYMPHONY OCT SYSTEM REDUCER KERRISON