SynFix-LR 08802016S

GUDID H98108802016S0

SYNFIX-LR 26MM DEPTH/32MM WIDTH/12MM HEIGHT 8DEG-STER

SYNTHES (U.S.A.) LP

Polymeric spinal interbody fusion cage

• Primary Device ID: H98108802016S0
• NIH Device Record Key: 6abd0cb8-4c1b-4f81-890b-eb2a35df03f9
• Commercial Distribution Discontinuation: 2021-09-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SynFix-LR
• Version Model Number: 08.802.016S
• Catalog Number: 08802016S
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034753980 [Primary]
HIBCC	H98108802016S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072253

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-13
• Device Publish Date: 2015-09-14

On-Brand Devices [SynFix-LR]

• H981608021030: MODULE FOR 4.0MM TI SYNFIX(TM)-LR LOCKING SCREWS
• 07611819297227: SCREW HOLDING INSTRUMENT FOR SYNFIX(TM)-LR
• 07611819297234: IMPLANT HOLDER FOR SYNFIX(TM)-LR
• H98108802004S0: SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/13.5MM HEIGHT 12DEG-STER
• H98108802003S0: SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/19MM HEIGHT 8DEG-STER
• H98108802002S0: SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/17MM HEIGHT 8DEG-STER
• H98108802001S0: SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/15MM HEIGHT 8DEG-STER
• H98108802000S0: SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/13.5MM HEIGHT 8DEG-STER
• H981048022130: 4.0MM TI LOCKING SCREW-FINE TIP 30MM FOR SYNFIX-LR
• 07611819310988: 19MM AIMING DEVICE-MODIFIED FOR SYNFIX-LR
• 07611819310971: 17MM AIMING DEVICE-MODIFIED FOR SYNFIX-LR
• 07611819310964: 15MM AIMING DEVICE-MODIFIED FOR SYNFIX-LR
• 07611819310957: 13.5MM AIMING DEVICE-MODIFIED FOR SYNFIX-LR
• 07611819310940: 12MM AIMING DEVICE-MODIFIED FOR SYNFIX-LR
• 07611819939028: SYNFIX(TM)-LR QUICK INSERTER/DISTRACTOR (SQUID)
• 07611819297425: PACKING BLOCK FOR 30MM DEPTH/ 38MM WIDTH SYNFIX(TM)-LR
• 07611819791268: PACKING BLOCK FOR 26MM DEPTH/ 32MM WIDTH SYNFIX(TM)-LR
• 07611819791251: AIMING DEVICE 15MM FOR SYNFIX(TM)-LR
• 07611819297272: AIMING DEVICE 19MM FOR SYNFIX(TM)-LR
• 07611819297265: AIMING DEVICE 17MM FOR SYNFIX(TM)-LR
• 07611819297258: AIMING DEVICE 13.5MM FOR SYNFIX(TM)-LR
• 07611819297197: AIMING DEVICE HOLDER FOR SYNFIX(TM)-LR
• 07611819973091: AIMING DEVICE FOR 12MM SYNFIX-LR
• 07611819973084: SYNFIX-LR TRIAL IMPLANT 12DEG DEPTH 30MM/W 38MM/H 12MM
• 07611819973077: SYNFIX-LR TRIAL IMPLANT 8DEG DEPTH 30MM/W 38MM/H 12MM
• 07611819973060: SYNFIX-LR TRIAL IMPLANT 12DEG DEPTH 26MM/W 32MM/H 12MM
• 07611819973053: SYNFIX-LR TRIAL IMPLANT 8DEG DEPTH 26MM/W 32MM/H 12MM
• H981608091500: SYNFIX® LR IMPLANT HOLDER GRAPHIC CASE
• H981608022400: MODULE FOR SYNFIX-LR AIMING DEVICES
• H981608021300: GRAPHIC CASE FOR SYNFIX-LR TRIAL SPACERS AND SCREWS
• H981608021100: GRAPHIC CASE FOR SYNFIX-LR STANDARD INSTRUMENTS
• H98108802019S0: SYNFIX-LR 30MM DEPTH/38MM WIDTH/12MM HEIGHT 12DEG-STER
• H98108802018S0: SYNFIX-LR 30MM DEPTH/38MM WIDTH/12MM HEIGHT 8DEG-STER
• H98108802017S0: SYNFIX-LR 26MM DEPTH/32MM WIDTH/12MM HEIGHT 12DEG-STER
• H98108802016S0: SYNFIX-LR 26MM DEPTH/32MM WIDTH/12MM HEIGHT 8DEG-STER
• H98108802015S0: SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/19MM HEIGHT 12DEG-STER
• H98108802014S0: SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/17MM HEIGHT 12DEG-STER
• H98108802013S0: SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/15MM HEIGHT 12DEG-STER
• H98108802012S0: SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/13.5MM HEIGHT 12DEG-STER
• H98108802011S0: SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/19MM HEIGHT 8DEG-STER
• H98108802010S0: SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/17MM HEIGHT 8DEG-STER
• H98108802009S0: SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/15MM HEIGHT 8DEG-STER
• H98108802008S0: SYNFIX(TM)-LR 30MM DEPTH/38MM WIDTH/13.5MM HEIGHT 8DEG-STER
• H98108802007S0: SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/19MM HEIGHT 12DEG-STER
• H98108802006S0: SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/17MM HEIGHT 12DEG-STER
• H98108802005S0: SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/15MM HEIGHT 12DEG-STER
• H981048022120: 4.0MM TI LOCKING SCREW-FINE TIP 25MM FOR SYNFIX-LR
• H981048022110: 4.0MM TI LOCKING SCREW-FINE TIP 20MM FOR SYNFIX-LR
• H981048022100: 4.0MM TI LOCKING SCREW-FINE TIP 15MM FOR SYNFIX-LR
• H981048022030: 4.0MM TI LOCKING SCREW 30MM FOR SYNFIX(TM)-LR