| Primary Device ID | H98108802014S0 |
| NIH Device Record Key | 7e868bc7-8320-4bf1-aad4-4b7c53d032d9 |
| Commercial Distribution Discontinuation | 2021-09-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | SynFix-LR |
| Version Model Number | 08.802.014S |
| Catalog Number | 08802014S |
| 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 |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034753966 [Primary] |
| HIBCC | H98108802014S0 [Secondary] |
| OVD | Intervertebral fusion device with integrated fixation, lumbar |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2022-01-19 |
| Device Publish Date | 2015-09-14 |
| 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 |