| Primary Device ID | 00815362022559 |
| NIH Device Record Key | 705ad233-3039-4f26-b09c-75dd07c96b08 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Interspinous Plate System |
| Version Model Number | 29-LV-4514 |
| Catalog Number | 29-LV-4514 |
| Company DUNS | 079398589 |
| Company Name | PRECISION SPINE, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815362022559 [Primary] |
| PEK | Spinous Process Plate |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
[00815362022559]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-11 |
| Device Publish Date | 2019-04-03 |
| 00815362022115 | 55mm Interspinous Female Plate |
| 00815362022108 | 50mm Interspinous Female Plate |
| 00815362022092 | 45mm Interspinous Female Plate |
| 00815362022085 | 40mm Interspinous Female Plate |
| 00815362022078 | 35mm Interspinous Female Plate |
| 00815362022061 | 55mm Interspinous Male Plate |
| 00815362022054 | 50mm Interspinous Male Plate |
| 00815362022047 | 45mm Interspinous Male Plate |
| 00815362022030 | 40mm Interspinous Male Plate |
| 00815362022023 | 35mm Interspinous Male Plate |
| 00815362022603 | Self Drilling Ø4.0mm Fixed Screw 12mm |
| 00815362022597 | Self Drilling Ø4.0mm Fixed Screw 10mm |
| 00815362022580 | Self Drilling Ø4.5mm Variable Screw 20mm |
| 00815362022573 | Self Drilling Ø4.5mm Variable Screw 18mm |
| 00815362022566 | Self Drilling Ø4.5mm Variable Screw 16mm |
| 00815362022559 | Self Drilling Ø4.5mm Variable Screw 14mm |
| 00815362022542 | Self Drilling Ø4.5mm Variable Screw 12mm |
| 00815362022535 | Self Drilling Ø4.5mm Variable Screw 10mm |
| 00815362022528 | Self Drilling Ø4.0mm Variable Screw 20mm |
| 00815362022511 | Self Drilling Ø4.0mm Variable Screw 18mm |
| 00815362022504 | Self Drilling Ø4.0mm Variable Screw 16mm |
| 00815362022498 | Self Drilling Ø4.0mm Variable Screw 14mm |
| 00815362022481 | Self Drilling Ø4.0mm Variable Screw 12mm |
| 00815362022474 | Self Drilling Ø4.0mm Variable Screw 10mm |
| 00815362022450 | AIO Final Tightener |
| 00815362022443 | AIO Cap Screw Inserter |
| 00815362022436 | All In One Inserter |
| 00815362022429 | 30mm Trial |
| 00815362022412 | 28mm Trial |
| 00815362022405 | 30mm Interspinous Female Plate |
| 00815362022399 | Reli™ SP 30mm Interspinous Male Plate |
| 00815362022382 | Reli™ SP 28mm Interspinous Female Plate |
| 00815362022375 | Reli™ SP 28mm Interspinous Male Plate |
| 00815362022351 | ISP Retractor Sterilization Case |
| 00815362022337 | ISP Sterilization Case |
| 00815362022320 | Straight Plate Holder |
| 00815362022313 | Plate Holder |
| 00815362022306 | 90mm Caspar Sleeve |
| 00815362022290 | 75mm Caspar Sleeve |
| 00815362022283 | Caspar Pin Driver |
| 00815362022276 | Caspar Retractor |
| 00815362022269 | 10mm Drill |
| 00815362022252 | Parallel Compressor |
| 00815362022245 | 55mm Trial |
| 00815362022238 | 50mm Trial |
| 00815362022221 | 45mm Trial |
| 00815362022214 | 40mm Trial |
| 00815362022207 | 35mm Trial |
| 00815362022191 | Tissue Awl |
| 00815362022184 | Counter Torque |