| Primary Device ID | M7404300038 |
| NIH Device Record Key | 87041608-9a45-4343-a553-8d9dad926fd7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CAPTURE Facet Screw Set System |
| Version Model Number | 70-02-033 |
| Catalog Number | 430-0038 |
| Company DUNS | 033014361 |
| Company Name | SPINEOLOGY INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| 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 | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M7404300038 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M7404300038]
Moist Heat or Steam Sterilization
[M7404300038]
Moist Heat or Steam Sterilization
[M7404300038]
Moist Heat or Steam Sterilization
[M7404300038]
Moist Heat or Steam Sterilization
[M7404300038]
Moist Heat or Steam Sterilization
[M7404300038]
Moist Heat or Steam Sterilization
[M7404300038]
Moist Heat or Steam Sterilization
[M7404300038]
Moist Heat or Steam Sterilization
[M7404300038]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-09-11 |
| Device Publish Date | 2024-05-24 |
| M7404300032 | Graft Spacer |
| M7404300031 | Rasp |
| M7404300030 | Dilator |
| M7404300029 | EMG Cannula |
| M7404300028 | Screw Remover |
| M7404300027 | Cannula cleaner |
| M7404300026 | Driver Cannula |
| M7404300025 | Driver Shaft |
| M7404300024 | Tap |
| M7404300023 | Drill Guide |
| M7403150015 | Capture Drill |
| M7404300038 | Palm Ratchet Handle |