| Primary Device ID | 00193082077227 |
| NIH Device Record Key | fe694f7f-d412-4df0-a294-9e1468b66e35 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AVANT MIS |
| Version Model Number | 6000-310-8B |
| Catalog Number | 6000-310-8B |
| Company DUNS | 783908713 |
| Company Name | SPINECRAFT, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(630)920-7300 |
| info@spinecraft.com | |
| Phone | +1(630)920-7300 |
| info@spinecraft.com | |
| Phone | +1(630)920-7300 |
| info@spinecraft.com | |
| Phone | +1(630)920-7300 |
| info@spinecraft.com | |
| Phone | +1(630)920-7300 |
| info@spinecraft.com | |
| Phone | +1(630)920-7300 |
| info@spinecraft.com | |
| Phone | +1(630)920-7300 |
| info@spinecraft.com | |
| Phone | +1(630)920-7300 |
| info@spinecraft.com | |
| Phone | +1(630)920-7300 |
| info@spinecraft.com | |
| Phone | +1(630)920-7300 |
| info@spinecraft.com | |
| Phone | +1(630)920-7300 |
| info@spinecraft.com | |
| Phone | +1(630)920-7300 |
| info@spinecraft.com | |
| Phone | +1(630)920-7300 |
| info@spinecraft.com | |
| Phone | +1(630)920-7300 |
| info@spinecraft.com | |
| Phone | +1(630)920-7300 |
| info@spinecraft.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00193082077227 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00193082077227]
Moist Heat or Steam Sterilization
[00193082077227]
Moist Heat or Steam Sterilization
[00193082077227]
Moist Heat or Steam Sterilization
[00193082077227]
Moist Heat or Steam Sterilization
[00193082077227]
Moist Heat or Steam Sterilization
[00193082077227]
Moist Heat or Steam Sterilization
[00193082077227]
Moist Heat or Steam Sterilization
[00193082077227]
Moist Heat or Steam Sterilization
[00193082077227]
Moist Heat or Steam Sterilization
[00193082077227]
Moist Heat or Steam Sterilization
[00193082077227]
Moist Heat or Steam Sterilization
[00193082077227]
Moist Heat or Steam Sterilization
[00193082077227]
Moist Heat or Steam Sterilization
[00193082077227]
Moist Heat or Steam Sterilization
[00193082077227]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-29 |
| Device Publish Date | 2019-04-19 |
| 00193082111631 | AVANT Dilator No.3 |
| 00193082111624 | AVANT Dilator No.2 |
| 00193082111617 | AVANT Dilator No.1 |
| 00193082111600 | AVANT RCDF Sleeve, Slim, Gen III |
| 00193082077333 | AVANT Extended Tab Anti-Torque |
| 00193082077326 | Extended Tab Clip, Titanium |
| 00193082077319 | Extended Tab Clip, Stainless Steel |
| 00193082077289 | AVANT RCDF Sleeve, Slim |
| 00193082077258 | AVANT Imaging Caliper |
| 00193082077241 | AVANT Calipers |
| 00193082077234 | Dia.5.5mm MIS Lordosed Rods Caddy |
| 00193082077227 | Dia.6mm MIS Lordosed Rods Caddy |
| 00193082077203 | AVANT MIS System Set Screw and Miscellaneous Implants Caddy |
| 00193082077197 | AVANT MIS System ASTRA Implant Case w / Dye Sublimation Graphics |
| 00193082077180 | AVANT Side Loading Counter Torque Handle |
| 00193082077173 | AVANT Extended Tab Remover |
| 00193082077166 | AVANT RCDF Sleeve |
| 00193082077159 | AVANT T30 Self-retaining Driver Constant Shaft |
| 00193082077142 | AVANT T30 Hexalobe Driver |
| 00193082077135 | AVANT Polyaxial Screwdriver |
| 00193082077128 | AVANT MIS System Instruments Case |
| 00193082152832 | AVANT Low Extended Tab Remover, 3D Printed |
| 00193082151347 | AVANT Calipers |
| 00193082150333 | AVANT Supplementary Implants Caddy |
| 00193082150302 | AVANT MIS System Instruments Case |
| 00193082077272 | AVANT Imaging Caliper Scale for MIS Rods |
| 00193082077265 | AVANT Imaging Caliper Scale for Lordosed Rods |
| 00193082154768 | MIS NavLock Polyaxial Screwdriver |
| 00193082153808 | RCDF Sleeve, Slim, Gen III |
| 00193082153792 | Dilator no.3 |
| 00193082114151 | SpineCraft Universal Metal Lid |
| 00193082077302 | Extended Tab Clip, Strong |
| 00193082077296 | Extended Tab Clip, Extra Strong |
| 00193082150326 | AVANT Set Screws and Miscellaneous Implants Caddy |
| 00193082150319 | AVANT MIS System - ASTRA Implants Case |
| 00193082152535 | AVANT Set Screw Loading Post |
| 00193082152528 | AIM Fulcrum Block, 35mm x 45mm |
| 00193082152511 | AIM Fulcrum Block, 35mm x 40mm |
| 00193082152504 | AIM Fulcrum Block, 30mm x 40mm |
| 00193082152498 | AIM Fulcrum Block, 30mm x 35mm |
| 00193082152481 | AIM Fulcrum Block, 25mm x 35mm |
| 00193082152474 | AIM Fulcrum Block, 25mm x 30mm |
| 00193082152467 | AIM Fulcrum Block, 20mm x 30mm |
| 00193082152450 | AIM Fulcrum Block, 20mm x 25mm |
| 00193082152443 | AIM Fulcrum Block, 15mm x 25mm |
| 00193082150241 | AIM Fulcrum Block, 15mm x 20mm |
| 00193082150234 | AVANT Extended Tab Remover |