| Primary Device ID | M739241645500 |
| NIH Device Record Key | 276ff23d-bbec-4216-8b0b-afc9e31f3984 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Polyaxial Reduction Screw 4.5 x 50mm |
| Version Model Number | 2416-4550 |
| Company DUNS | 836975784 |
| Company Name | CAPTIVA SPINE, INC. |
| 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 | 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 | 561-277-9480 |
| info@captivaspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M739241645500 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M739241645500]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-09 |
| Device Publish Date | 2020-04-01 |
| 00850065741567 - Trial 7mm | 2025-08-27 7mm Trial |
| 00850065741574 - Trial 8mm | 2025-08-27 8mm Trial |
| 00850065741581 - Trial 9mm | 2025-08-27 9mm Trial |
| 00850065741598 - Trial 10mm | 2025-08-27 10mm Trial |
| 00850065741604 - Trial 11mm | 2025-08-27 11mm Trial |
| 00850065741611 - Trial 12mm | 2025-08-27 12mm Trial |
| 00850065741628 - Distraction Paddle - 7mm | 2025-08-27 Distraction Paddle - 7mm |
| 00850065741635 - Distraction Paddle - 8mm | 2025-08-27 Distraction Paddle - 8mm |