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 |