| Primary Device ID | M739245521300 |
| NIH Device Record Key | 94813fe5-6a0c-4e2a-9a7d-e1c6a6927b80 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Curved Rod, 5.5 x 130 mm |
| Version Model Number | 2455-2130 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M739245521300 [Primary] |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M739245521300]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-08 |
| Device Publish Date | 2019-03-29 |
| M739102900109 - TransFasten - LSF, General Instrument Tray | 2024-05-03 Sterilization Case - General Instrument Tray |
| M73910290020 - TransFasten - LSF, Quick Connect Drill | 2024-05-03 Quick Connect Drill |
| M73910290030 - TransFasten-LSF, Tissue Protector | 2024-05-03 Tissue Protector |
| M73910290050 - TransFasten-LSF, Implant Driver Shaft | 2024-05-03 Implant Driver Shaft |
| M73910290060 - TransFasten-LSF, Offset Guide | 2024-05-03 Offset Guide |
| M73910290070 - TransFasten-LSF, Tissue Dilator | 2024-05-03 Tissue Dilator |
| M739102901009 - TransFasten-LSF, Plunger Rod | 2024-05-03 Plunger Rod |
| M73910290110 - TransFasten - LSF, Implant Filling Tube | 2024-05-03 Implant Filling Tube |