| Primary Device ID | 00193082077760 | 
| NIH Device Record Key | 935ec839-1812-40e9-949f-c7601b025df2 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | ALLTUM | 
| Version Model Number | 4010-04 | 
| Catalog Number | 4010-04 | 
| 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 | 00193082077760 [Primary] | 
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00193082077760]
Moist Heat or Steam Sterilization
[00193082077760]
Moist Heat or Steam Sterilization
[00193082077760]
Moist Heat or Steam Sterilization
[00193082077760]
Moist Heat or Steam Sterilization
[00193082077760]
Moist Heat or Steam Sterilization
[00193082077760]
Moist Heat or Steam Sterilization
[00193082077760]
Moist Heat or Steam Sterilization
[00193082077760]
Moist Heat or Steam Sterilization
[00193082077760]
Moist Heat or Steam Sterilization
[00193082077760]
Moist Heat or Steam Sterilization
[00193082077760]
Moist Heat or Steam Sterilization
[00193082077760]
Moist Heat or Steam Sterilization
[00193082077760]
Moist Heat or Steam Sterilization
[00193082077760]
Moist Heat or Steam Sterilization
[00193082077760]
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 | 
| 00193082077838 | ALLTUM Plate Bender | 
| 00193082077821 | Combination Screwdriver w/ Solid Pin | 
| 00193082077807 | Cam Locker w/ Stainless Steel Sleeve | 
| 00193082077791 | Cam Locker w/ Titanium Sleeve | 
| 00193082077784 | ALLTUM Screw Remover | 
| 00193082077777 | ALLTUM Screw Extractor | 
| 00193082077760 | ALLTUM Variable Angle Drill Guide | 
| 00193082077753 | Screw Removal Sleeve | 
| 00193082077746 | ALLTUM Screwdriver | 
| 00193082077739 | ALLTUM Dia.4.5mm Screw Caddy | 
| 00193082077722 | ALLTUM Dia.4.0mm Screw Caddy | 
| 00193082077715 | ALLTUM Four Level Plate Caddy | 
| 00193082077708 | ALLTUM Three Level Plate Caddy | 
| 00193082077692 | ALLTUM One and Two Level Plate Caddy | 
| 00193082077685 | ALLTUM ACP System, Implants and Instruments Case | 
| 00193082000560 | ALLTUM ACP Screw - Variable, DIA.4.5 L18mm | 
| 00193082000553 | ALLTUM ACP Screw - Variable, DIA.4.5 L16mm | 
| 00193082000546 | ALLTUM ACP Screw - Variable, DIA.4.5 L14mm | 
| 00193082000539 | ALLTUM ACP Screw - Variable, DIA.4.5 L12mm | 
| 00193082000522 | ALLTUM ACP Screw - Variable, DIA.4 L18mm | 
| 00193082000515 | ALLTUM ACP Screw - Variable, DIA.4 L16mm | 
| 00193082000508 | ALLTUM ACP Screw - Variable, DIA.4 L14mm | 
| 00193082000492 | ALLTUM ACP Screw - Variable, DIA.4 L12mm | 
| 00193082000485 | ALLTUM ACP Screw - Fixed, DIA.4.5 L18mm | 
| 00193082000478 | ALLTUM ACP Screw - Fixed, DIA.4.5 L16mm | 
| 00193082000461 | ALLTUM ACP Screw - Fixed, DIA.4.5 L14mm | 
| 00193082000454 | ALLTUM ACP Screw - Fixed, DIA.4.5 L12mm | 
| 00193082000447 | ALLTUM ACP Screw - Fixed, DIA.4 L18mm | 
| 00193082000430 | ALLTUM ACP Screw - Fixed, DIA.4 L16mm | 
| 00193082000423 | ALLTUM ACP Screw - Fixed, DIA.4 L14mm | 
| 00193082000416 | ALLTUM ACP Screw - Fixed, DIA.4 L12mm | 
| 00193082000409 | ALLTUM Anterior Cervical Plate - 4 Levels, L96mm | 
| 00193082000393 | ALLTUM Anterior Cervical Plate - 4 Levels, L92mm | 
| 00193082000386 | ALLTUM Anterior Cervical Plate - 4 Levels, L88mm | 
| 00193082000379 | ALLTUM Anterior Cervical Plate - 4 Levels, L84mm | 
| 00193082000362 | ALLTUM Anterior Cervical Plate - 4 Levels, L80mm | 
| 00193082000355 | ALLTUM Anterior Cervical Plate - 4 Levels, L76mm | 
| 00193082000348 | ALLTUM Anterior Cervical Plate - 4 Levels, L72mm | 
| 00193082000331 | ALLTUM Anterior Cervical Plate - 4 Levels, L68mm | 
| 00193082000324 | ALLTUM Anterior Cervical Plate - 4 Levels, L64mm | 
| 00193082000317 | ALLTUM Anterior Cervical Plate - 4 Levels, L60mm | 
| 00193082000300 | ALLTUM Anterior Cervical Plate - 3 Levels, L69mm | 
| 00193082000294 | ALLTUM Anterior Cervical Plate - 3 Levels, L66mm | 
| 00193082000287 | ALLTUM Anterior Cervical Plate - 3 Levels, L63mm | 
| 00193082000270 | ALLTUM Anterior Cervical Plate - 3 Levels, L60mm | 
| 00193082000263 | ALLTUM Anterior Cervical Plate - 3 Levels, L57mm | 
| 00193082000256 | ALLTUM Anterior Cervical Plate - 3 Levels, L54mm | 
| 00193082000249 | ALLTUM Anterior Cervical Plate - 3 Levels, L51mm | 
| 00193082000232 | ALLTUM Anterior Cervical Plate - 3 Levels, L48mm | 
| 00193082000225 | ALLTUM Anterior Cervical Plate - 3 Levels, L45mm |