| Primary Device ID | 10889981096205 |
| NIH Device Record Key | de6f1ee2-8c4a-4ed6-a348-298dcafc3200 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spinous Process System |
| Version Model Number | 95-3021 |
| Catalog Number | 95-3021 |
| Company DUNS | 079840876 |
| Company Name | SEASPINE ORTHOPEDICS CORPORATION |
| 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(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981096205 [Primary] |
| HWN | INSTRUMENT, COMPRESSION |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981096205]
Moist Heat or Steam Sterilization
[10889981096205]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-05-21 |
| Device Publish Date | 2018-04-18 |
| 10889981129705 | Plate Inserter, Spinous Process Spacer |
| 10889981129613 | Spinous Process Implants and Instruments |
| 10889981120603 | Spinous Process Tray, Caddy |
| 10889981096281 | 16mm Trial, Spinous Process Spacer |
| 10889981096274 | 14mm Trial, Spinous Process Spacer |
| 10889981096267 | 12mm Trial, Spinous Process Spacer |
| 10889981096250 | 10mm Trial, Spinous Process Spacer |
| 10889981096243 | 8mm Trial, Spinous Process Spacer |
| 10889981096236 | 6mm Trial, Spinous Process Spacer |
| 10889981096205 | Compressor, Spinous Process Spacer |
| 10889981096199 | Inserter, Spinous Process Spacer |
| 10889981096175 | Ligament Splitter |
| 10889981096151 | T15 Driver |
| 10889981076238 | Spinous Process Spacer, 16mm |
| 10889981076221 | Spinous Process Spacer, 14mm |
| 10889981076214 | Spinous Process Spacer, 12mm |
| 10889981076207 | Spinous Process Spacer, 10mm |
| 10889981076191 | Spinous Process Spacer, 8mm |
| 10889981076184 | Spinous Process Spacer, 6mm |