| Primary Device ID | H981036477880 |
| NIH Device Record Key | b188489d-38fc-46f6-b0ba-58363ff33a10 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zero-P VA |
| Version Model Number | 03.647.788 |
| Catalog Number | 03647788 |
| Company DUNS | 486711679 |
| Company Name | Synthes GmbH |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07611819404311 [Direct Marking] |
| GS1 | 10705034720630 [Primary] |
| HIBCC | H981036477880 [Secondary] |
| OVE | Intervertebral fusion device with integrated fixation, cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[H981036477880]
Moist Heat or Steam Sterilization
[H981036477880]
Moist Heat or Steam Sterilization
[H981036477880]
Moist Heat or Steam Sterilization
[H981036477880]
Moist Heat or Steam Sterilization
[H981036477880]
Moist Heat or Steam Sterilization
[H981036477880]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2022-06-01 |
| Device Publish Date | 2015-09-14 |
| H98104647136S0 | ZERO-P VA IMPLANT 6MM HEIGHT CONVEX-STERILE |
| 07611819404502 | PACKING BLOCK FOR ZERO-P VA IMPLANTS |
| H981036477990 | ZERO-P VA TRIAL SPACER W/STOP CONVEX/LARGE/9MM HEIGHT |
| H981036477980 | ZERO-P VA TRIAL SPACER W/STOP CONVEX/LARGE/8MM HEIGHT |
| H981036477970 | ZERO-P VA TRIAL SPACER W/STOP CONVEX/LARGE/7MM HEIGHT |
| H981036477960 | ZERO-P VA TRIAL SPACER W/STOP CONVEX/LARGE/6MM HEIGHT |
| H981036477950 | ZERO-P VA TRIAL SPACER W/STOP CONVEX/LARGE/5MM HEIGHT |
| H981036477920 | ZERO-P VA TRIAL SPACER W/STOP CONVEX/LARGE/12MM HEIGHT |
| H981036477910 | ZERO-P VA TRIAL SPACER W/STOP CONVEX/LARGE/11MM HEIGHT |
| H981036477900 | ZERO-P VA TRIAL SPACER W/STOP CONVEX/LARGE/10MM HEIGHT |
| H981036477890 | ZERO-P VA TRIAL SPACER W/STOP CONVEX/9MM HEIGHT |
| H981036477880 | ZERO-P VA TRIAL SPACER W/STOP CONVEX/8MM HEIGHT |
| H981036477870 | ZERO-P VA TRIAL SPACER W/STOP CONVEX/7MM HEIGHT |
| H981036477860 | ZERO-P VA TRIAL SPACER W/STOP CONVEX/6MM HEIGHT |
| H981036477850 | ZERO-P VA TRIAL SPACER W/STOP CONVEX/5MM HEIGHT |
| H981036477820 | ZERO-P VA TRIAL SPACER W/STOP CONVEX/12MM HEIGHT |
| H981036477810 | ZERO-P VA TRIAL SPACER W/STOP CONVEX/11MM HEIGHT |
| H981036477800 | ZERO-P VA TRIAL SPACER W/STOP CONVEX/10MM HEIGHT |
| H981036477690 | ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/LARGE/9MM HEIGHT |
| H981036477680 | ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/LARGE/8MM HEIGHT |
| H981036477670 | ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/LARGE/7MM HEIGHT |
| H981036477660 | ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/LARGE/6MM HEIGHT |
| H981036477650 | ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/LARGE/5MM HEIGHT |
| H981036477620 | ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/LARGE/12MM HEIGHT |
| H981036477610 | ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/LARGE/11MM HEIGHT |
| H981036477600 | ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/LARGE/10MM HEIGHT |
| H981036477590 | ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/9MM HEIGHT |
| H981036477580 | ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/8MM HEIGHT |
| H981036477570 | ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/7MM HEIGHT |
| H981036477560 | ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/6MM HEIGHT |
| H981036477550 | ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/5MM HEIGHT |
| H981036477520 | ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/12MM HEIGHT |
| H981036477510 | ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/11MM HEIGHT |
| H981036477500 | ZERO-P VA TRIAL SPACER W/STOP LORDOTIC/10MM HEIGHT |
| H981036477380 | ZERO-P VA TRIAL SPACER W/STOP PARALLEL/LARGE/8MM HEIGHT |
| H981036477370 | ZERO-P VA TRIAL SPACER W/STOP PARALLEL/LARGE/7MM HEIGHT |
| H981036477360 | ZERO-P VA TRIAL SPACER W/STOP PARALLEL/LARGE/6MM HEIGHT |
| H981036477350 | ZERO-P VA TRIAL SPACER W/STOP PARALLEL/LARGE/5MM HEIGHT |
| H981036477320 | ZERO-P VA TRIAL SPACER W/STOP PARALLEL/LARGE/12MM HEIGHT |
| H981036477310 | ZERO-P VA TRIAL SPACER W/STOP PARALLEL/LARGE/11MM HEIGHT |
| H981036477300 | ZERO-P VA TRIAL SPACER W/STOP PARALLEL/LARGE/10MM HEIGHT |
| H981036477290 | ZERO-P VA TRIAL SPACER W/STOP PARALLEL/9MM HEIGHT |
| H981036477280 | ZERO-P VA TRIAL SPACER W/STOP PARALLEL/8MM HEIGHT |
| H981036477270 | ZERO-P VA TRIAL SPACER W/STOP PARALLEL/7MM HEIGHT |
| H981036477260 | ZERO-P VA TRIAL SPACER W/STOP PARALLEL/6MM HEIGHT |
| H981036477250 | ZERO-P VA TRIAL SPACER W/STOP PARALLEL/5MM HEIGHT |
| H981036477220 | ZERO-P VA TRIAL SPACER W/STOP PARALLEL/12MM HEIGHT |
| H981036477210 | ZERO-P VA TRIAL SPACER W/STOP PARALLEL/11MM HEIGHT |
| H981036477200 | ZERO-P VA TRIAL SPACER W/STOP PARALLEL/10MM HEIGHT |
| H981036477390 | ZERO-P VA TRIAL SPACER W/STOP PARALLEL/LARGE/9MM HEIGHT |