| Primary Device ID | H9816900970 |
| NIH Device Record Key | 5cb23391-c8a6-4147-9d8d-860f2be941ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ATB |
| Version Model Number | 690.097 |
| Catalog Number | 690097 |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | |
| 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 | |
| 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 | 10705034798998 [Primary] |
| HIBCC | H9816900970 [Secondary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
[H9816900970]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-10-21 |
| Device Publish Date | 2016-12-31 |
| H9816900840 | MODULE FOR ANTERIOR TENSION BAND TWO LEVEL LUMBAR PLATES |
| H9816900830 | MODULE FOR ANTERIOR TENSION BAND TWO LEVEL SACRAL PLATES |
| H9816900820 | MODULE FOR ANTERIOR TENSION BAND ONE LEVEL SACRAL PLATES |
| H9816900810 | MODULE FOR ANTERIOR TENSION BAND ONE LEVEL LUMBAR PLATES |
| H9816900980 | MODULE F/ANTERIOR TENSION BAND 2 LVL SYMMETRICAL SACRAL PL |
| H9816900970 | MODULE F/ANTERIOR TENSION BAND 2 LVL SYMMETRICAL LUMBAR PL |
| 07611819776036 | GRAPHIC CASE FOR ANTERIOR TENSION BAND IMPLANT SET |
| 07611819776029 | GRAPHIC CASE FOR ANTERIOR TENSION BAND INSTRUMENT SET |
| H9814491360 | TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL SACRAL/101M |
| H9814491350 | TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL SACRAL/97MM |
| H9814491340 | TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL SACRAL/93MM |
| H9814491330 | TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL SACRAL/89MM |
| H9814491320 | TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL SACRAL/85MM |
| H9814491310 | TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL SACRAL/81MM |
| H9814491300 | TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL SACRAL/77MM |
| H9814491280 | TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL LUMBAR/109M |
| H9814491270 | TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL LUMBAR/105M |
| H9814491260 | TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL LUMBAR/101M |
| H9814491250 | TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL LUMBAR/97MM |
| H9814491240 | TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL LUMBAR/93MM |
| H9814491230 | TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL LUMBAR/89MM |
| H9814491220 | TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL LUMBAR/85MM |
| H9814491210 | TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL LUMBAR/81MM |
| H9814491200 | TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL LUMBAR/77MM |
| H9814491070 | TI ANTERIOR TENSION BAND PLATE TWO LEVEL SACRAL/101MM |
| H9814491060 | TI ANTERIOR TENSION BAND PLATE TWO LEVEL SACRAL/97MM |
| H9814491050 | TI ANTERIOR TENSION BAND PLATE TWO LEVEL SACRAL/93MM |
| H9814491040 | TI ANTERIOR TENSION BAND PLATE TWO LEVEL SACRAL/89MM |
| H9814491030 | TI ANTERIOR TENSION BAND PLATE TWO LEVEL SACRAL/85MM |
| H9814491020 | TI ANTERIOR TENSION BAND PLATE TWO LEVEL SACRAL/81MM |
| H9814491010 | TI ANTERIOR TENSION BAND PLATE TWO LEVEL SACRAL/77MM |
| H9814490890 | TI ANTERIOR TENSION BAND PLATE TWO LEVEL LUMBAR/109MM |
| H9814490880 | TI ANTERIOR TENSION BAND PLATE TWO LEVEL LUMBAR/105MM |
| H9814490870 | TI ANTERIOR TENSION BAND PLATE TWO LEVEL LUMBAR/101MM |
| H9814490860 | TI ANTERIOR TENSION BAND PLATE TWO LEVEL LUMBAR/97MM |
| H9814490850 | TI ANTERIOR TENSION BAND PLATE TWO LEVEL LUMBAR/93MM |
| H9814490840 | TI ANTERIOR TENSION BAND PLATE TWO LEVEL LUMBAR/89MM |
| H9814490830 | TI ANTERIOR TENSION BAND PLATE TWO LEVEL LUMBAR/85MM |
| H9814490820 | TI ANTERIOR TENSION BAND PLATE TWO LEVEL LUMBAR/81MM |
| H9814490810 | TI ANTERIOR TENSION BAND PLATE TWO LEVEL LUMBAR/77MM |
| H9814490770 | TI ANTERIOR TENSION BAND PLATE ONE LEVEL SACRAL/47MM |
| H9814490760 | TI ANTERIOR TENSION BAND PLATE ONE LEVEL SACRAL/45MM |
| H9814490750 | TI ANTERIOR TENSION BAND PLATE ONE LEVEL SACRAL/43MM |
| H9814490740 | TI ANTERIOR TENSION BAND PLATE ONE LEVEL SACRAL/41MM |
| H9814490730 | TI ANTERIOR TENSION BAND PLATE ONE LEVEL SACRAL/39MM |
| H9814490720 | TI ANTERIOR TENSION BAND PLATE ONE LEVEL SACRAL/37MM |
| H9814490710 | TI ANTERIOR TENSION BAND PLATE ONE LEVEL SACRAL/35MM |
| H9814490690 | TI ANTERIOR TENSION BAND PLATE ONE LEVEL LUMBAR/51MM |
| H9814490680 | TI ANTERIOR TENSION BAND PLATE ONE LEVEL LUMBAR/49MM |
| H9814490670 | TI ANTERIOR TENSION BAND PLATE ONE LEVEL LUMBAR/47MM |