| Primary Device ID | 00850039803000 |
| NIH Device Record Key | ffcbfcf5-545b-4889-8d7f-7fa61a266388 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Continuum |
| Version Model Number | PS-01-1412A |
| Company DUNS | 084706556 |
| Company Name | Pressio, Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 866-648-4665 |
| info@pressiospine.com | |
| Phone | 866-648-4665 |
| info@pressiospine.com | |
| Phone | 866-648-4665 |
| info@pressiospine.com | |
| Phone | 866-648-4665 |
| info@pressiospine.com | |
| Phone | 866-648-4665 |
| info@pressiospine.com | |
| Phone | 866-648-4665 |
| info@pressiospine.com | |
| Phone | 866-648-4665 |
| info@pressiospine.com | |
| Phone | 866-648-4665 |
| info@pressiospine.com | |
| Phone | 866-648-4665 |
| info@pressiospine.com | |
| Phone | 866-648-4665 |
| info@pressiospine.com | |
| Phone | 866-648-4665 |
| info@pressiospine.com | |
| Phone | 866-648-4665 |
| info@pressiospine.com | |
| Phone | 866-648-4665 |
| info@pressiospine.com | |
| Phone | 866-648-4665 |
| info@pressiospine.com | |
| Phone | 866-648-4665 |
| info@pressiospine.com | |
| Phone | 866-648-4665 |
| info@pressiospine.com | |
| Phone | 866-648-4665 |
| info@pressiospine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850039803000 [Primary] |
| PHQ | Anterior Staple As Supplemental Fixation For Fusion |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-09 |
| Device Publish Date | 2023-05-01 |
| 00850039803079 | ACDF IMPLANT KIT - 20X12MM STRAIGHT |
| 00850039803062 | ACDF IMPLANT KIT - 18X12MM STRAIGHT |
| 00850039803055 | ACDF IMPLANT KIT - 16X12MM STRAIGHT |
| 00850039803048 | ACDF IMPLANT KIT - 14X12MM STRAIGHT |
| 00850039803031 | ACDF IMPLANT KIT - 20X12MM ANGLED |
| 00850039803024 | ACDF IMPLANT KIT - 18X12MM ANGLED |
| 00850039803017 | ACDF IMPLANT KIT - 16X12MM ANGLED |
| 00850039803000 | ACDF IMPLANT KIT - 14X12MM ANGLED |