| Primary Device ID | 00193082152436 |
| NIH Device Record Key | 90cd9f46-d9ae-4195-8dc5-6bab35d7ab60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AIM MIS |
| Version Model Number | 6100-12KB |
| Catalog Number | 6100-12KB |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00193082152436 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00193082152436]
Moist Heat or Steam Sterilization
[00193082152436]
Moist Heat or Steam Sterilization
[00193082152436]
Moist Heat or Steam Sterilization
[00193082152436]
Moist Heat or Steam Sterilization
[00193082152436]
Moist Heat or Steam Sterilization
[00193082152436]
Moist Heat or Steam Sterilization
[00193082152436]
Moist Heat or Steam Sterilization
[00193082152436]
Moist Heat or Steam Sterilization
[00193082152436]
Moist Heat or Steam Sterilization
[00193082152436]
Moist Heat or Steam Sterilization
[00193082152436]
Moist Heat or Steam Sterilization
[00193082152436]
Moist Heat or Steam Sterilization
[00193082152436]
Moist Heat or Steam Sterilization
[00193082152436]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-09-16 |
| Device Publish Date | 2020-09-19 |
| 00193082052484 | Silicone Overmolded Reusable Rod Template, Dia.5mm, Measurements to 150 |
| 00193082052477 | Insulating Dilator |
| 00193082052460 | Dilator No.2, Anodized |
| 00193082052453 | Parallel Distractor w/ Compression Ring |
| 00193082052446 | Compressor Distractor Combination Device |
| 00193082052439 | Rod Pass Indicator |
| 00193082052422 | AIM MIS Tube |
| 00193082052415 | MIS Polyaxial screwdriver, Fitted |
| 00193082052408 | Counter-Torque |
| 00193082052392 | Fulcrum Block |
| 00193082052385 | Fulcrum Block |
| 00193082052378 | Fulcrum Block |
| 00193082052361 | Distraction Forceps |
| 00193082052354 | Compression Forceps |
| 00193082052347 | Compression Forceps with Hooks |
| 00193082052330 | Reduction forceps |
| 00193082052323 | T30 Self-retaining driver |
| 00193082052316 | T30 Centering Sleeve |
| 00193082052309 | Rod Introducer w/ Stopper |
| 00193082052293 | Rod Introducer (w/knob) |
| 00193082052286 | Rod Introducer |
| 00193082052279 | Rod Holder |
| 00193082052262 | MIS Polyaxial screwdriver |
| 00193082052255 | MIS Tube (Screw Tower) |
| 00193082052248 | Insulating Dilator |
| 00193082052231 | Dilator No.2 |
| 00193082052224 | Dilator No.1 |
| 00193082052217 | AIM CDF Sleeve |
| 00193082052200 | K-Wire w/ Threaded End - Nitinol |
| 00193082052194 | K-Wire w/ Threaded End - Stainless Steel |
| 00193082052170 | AIM Spine MIS Instrument Case |
| 00193082113338 | AIM T-30 Self-retaining Driver |
| 00193082155284 | AIM CDF Sleeve, SM |
| 00193082155277 | AIM CDF Sleeve, MD |
| 00193082153969 | dia.1,5 K-wire w/ single round threaded end (316 LVM), 500mm |
| 00193082153785 | AIM Compression Forceps with Hooks |
| 00193082153778 | AIM Fulcrum Block, 35mm x 45mm |
| 00193082153761 | AIM Fulcrum Block, 35mm x 40mm |
| 00193082153754 | AIM Fulcrum Block, 30mm x 40mm |
| 00193082153747 | AIM Fulcrum Block, 30mm x 35mm |
| 00193082153730 | AIM Fulcrum Block, 25mm x 35mm |
| 00193082153723 | AIM Fulcrum Block, 25mm x 30mm |
| 00193082153716 | AIM Fulcrum Block, 20mm x 30mm |
| 00193082153709 | AIM Fulcrum Block, 20mm x 25mm |
| 00193082153693 | AIM Fulcrum Block, 15mm x 25mm |
| 00193082153686 | AIM Fulcrum Block, 15mm x 20mm |
| 00193082152436 | AIM Rod Introducer |
| 00193082150227 | AIM Rod Holder |
| 00193082150210 | AIM Rod Introducer with Stopper |
| 00193082150258 | Dia. 1,5 K-wire w/ single round threaded end (Nitinol), 500mm |