| Primary Device ID | 00842166121546 |
| NIH Device Record Key | ad99adbc-3cee-46b5-9e0f-2847fb2583f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zavation ZVplasty System Assembly |
| Version Model Number | VCF-1015-1-E |
| Company DUNS | 069472800 |
| Company Name | Zavation LLC |
| 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 | 6019191119 |
| info@zavation.com | |
| Phone | 6019191119 |
| info@zavation.com | |
| Phone | 6019191119 |
| info@zavation.com | |
| Phone | 6019191119 |
| info@zavation.com | |
| Phone | 6019191119 |
| info@zavation.com | |
| Phone | 6019191119 |
| info@zavation.com | |
| Phone | 6019191119 |
| info@zavation.com | |
| Phone | 6019191119 |
| info@zavation.com | |
| Phone | 6019191119 |
| info@zavation.com | |
| Phone | 6019191119 |
| info@zavation.com | |
| Phone | 6019191119 |
| info@zavation.com | |
| Phone | 6019191119 |
| info@zavation.com | |
| Phone | 6019191119 |
| info@zavation.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842166121546 [Primary] |
| NDN | Cement, Bone, Vertebroplasty |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00842166121546]
Ethylene Oxide
[00842166121546]
Ethylene Oxide
[00842166121546]
Ethylene Oxide
[00842166121546]
Ethylene Oxide
[00842166121546]
Ethylene Oxide
[00842166121546]
Ethylene Oxide
[00842166121546]
Ethylene Oxide
[00842166121546]
Ethylene Oxide
[00842166121546]
Ethylene Oxide
[00842166121546]
Ethylene Oxide
[00842166121546]
Ethylene Oxide
[00842166121546]
Ethylene Oxide
[00842166121546]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-11 |
| Device Publish Date | 2024-11-01 |
| 00197157016791 - ZAVATION ROD CONNECTOR | 2025-06-13 ROD CONNECTOR, PARALLEL TOP LOADING 14mm offset,5.5/6.0mm X 5.5/6.0mm |
| 00197157016807 - ZAVATION ROD CONNECTOR | 2025-06-13 ROD CONNECTOR, PARALLEL TOP LOADING 10° offset,5.5/6.0mm X 5.5/6.0mm |
| 00197157016814 - ZAVATION ROD CONNECTOR | 2025-06-13 ROD CONNECTOR, PARALLEL TOP LOADING 20°offset,5.5/6.0mm X 5.5/6.0mm |
| 00197157016821 - ZAVATION ROD CONNECTOR | 2025-06-13 ROD CONNECTOR, PARALLEL TOP LOADING 30°offset,5.5/6.0mm X 5.5/6.0mm |
| 00197157016838 - ZAVATION ROD CONNECTOR | 2025-06-13 ROD CONNECTOR, AXIAL CLOSED mm offset,3.5/4.0mm X 4.75/5.5mm |
| 00197157016845 - ZAVATION ROD CONNECTOR | 2025-06-13 ROD CONNECTOR, AXIAL CLOSED mm offset,3.5/4.0mm X 5.5/6.0mm |
| 00197157016852 - ZAVATION ROD CONNECTOR | 2025-06-13 ROD CONNECTOR, AXIAL CLOSED mm offset,4.75/5.5mm X 4.75/5.5mm |
| 00197157016869 - ZAVATION ROD CONNECTOR | 2025-06-13 ROD CONNECTOR, AXIAL CLOSED mm offset,4.75/5.5mm X 5.5/6.0mm |