APEX Spine System
GUDID M824SCMR67055F1
Monoaxial Reduction Screw, 7.00 x 55mm, Self-Tapping
SPINECRAFT, LLC
Spinal bone screw, non-bioabsorbable| Primary Device ID | M824SCMR67055F1 |
| NIH Device Record Key | de2344a2-1add-4a41-b2ad-bcab6a4f29e2 |
| Commercial Distribution Discontinuation | 2024-09-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | APEX Spine System |
| Version Model Number | SC-MR6-7055-F |
| Company DUNS | 783908713 |
| Company Name | SPINECRAFT, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
Customer Support Contacts
| 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 | |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M824SCMR67055F1 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K062513
FDA Product Code
| NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
[M824SCMR67055F1]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-09-05 |
| Device Publish Date | 2014-09-24 |
On-Brand Devices [APEX Spine System]
| 00193082031021 | APEX C-Block |
| 00193082031014 | APEX Demi Open-Closed Side-by-Side Rod Connector Dia.5.50 to Dia.5.50 |
| 00193082031007 | APEX Open-Closed Side-by-Side Rod Connector Dia.5.50 to Dia.5.50 |
| 00193082030994 | APEX Demi Open-Closed Side-by-Side Rod Connector Dia.6 to Dia.5.50 |
| 00193082030987 | APEX Open-Closed Side-by-Side Rod Connector Dia.6 to Dia.5.50 |
| 00193082030970 | APEX Demi Open-Closed Side-by-Side Rod Connector Dia.6 to Dia.6 |
| 00193082030963 | APEX Open-Closed Side-by-Side Rod Connector Dia.6 to Dia.6 |
| 00193082030956 | APEX Tandem Rod Connector Dia.5.50 to Dia.5.50mm- Growing Rod, 80mm |
| 00193082030949 | APEX Tandem Rod Connector Dia.5.50 to Dia.5.50mm- Growing Rod, 70mm |
| 00193082030932 | APEX Tandem Rod Connector Dia.5.50 to Dia.5.50mm- Growing Rod, 60mm |
| 00193082030925 | APEX Tandem Rod Connector Dia.5.50 to Dia.5.50mm- Growing Rod, 50mm |
| 00193082030918 | APEX Tandem Rod Connector Dia.5.50 to Dia.5.50mm- Growing Rod, 40mm |
| 00193082030901 | APEX Tandem Rod Connector Dia.5.50mm |
| 00193082030895 | APEX Demi Side-by-Side Rod Connector Dia.5.50mm |
| 00193082030888 | APEX Side-by-Side Rod Connector Dia.5.50mm |
| 00193082030871 | APEX Tandem Rod Connector Dia.6.00 to Dia.6.00mm- Growing Rod, 80mm |
| 00193082030864 | APEX Tandem Rod Connector Dia.6.00 to Dia.6.00mm- Growing Rod, 70mm |
| 00193082030857 | APEX Tandem Rod Connector Dia.6.00 to Dia.6.00mm- Growing Rod, 60mm |
| 00193082030840 | APEX Tandem Rod Connector Dia.6.00 to Dia.6.00mm- Growing Rod, 50mm |
| 00193082030833 | APEX Tandem Rod Connector Dia.6.00 to Dia.6.00mm- Growing Rod, 40mm |
| 00193082030826 | APEX Tandem Rod Connector Dia.5.50 to Dia.6.00mm- Growing Rod, 80mm |
| 00193082030819 | APEX Tandem Rod Connector Dia.5.50 to Dia.6.00mm- Growing Rod, 70mm |
| 00193082030802 | APEX Tandem Rod Connector Dia.5.50 to Dia.6.00mm- Growing Rod, 60mm |
| 00193082030796 | APEX Tandem Rod Connector Dia.5.50 to Dia.6.00mm- Growing Rod, 50mm |
| 00193082030789 | APEX Tandem Rod Connector Dia.5.50 to Dia.6.00mm- Growing Rod, 40mm |
| 00193082030772 | APEX Tandem Rod Connector Dia.5.50 to Dia.6mm |
| 00193082030765 | APEX Demi Side-by-Side Rod Connector Dia.5.50 to Dia.6mm |
| 00193082030758 | APEX Side-by-Side Rod Connector Dia.5.50 to Dia.6mm |
| 00193082030741 | APEX Tandem Rod Connector Dia.6mm |
| 00193082030734 | APEX Demi Side-by Side Rod Connector Dia.6mm |
| 00193082030727 | APEX Side-by-Side Rod Connector Dia.6mm |
| 00193082030710 | APEX M6 Set Screw for Lateral Slotted Connectors |
| 00193082030703 | APEX XL T30 Set Screw |
| 00193082030697 | APEX T-30 Set Screws 11.0mm OD for Large Poly Screws |
| 00193082030680 | APEX T-30 Set Screw, 9.5mm OD for Mono, Poly Screws and Hooks |
| 00193082030673 | APEX T-20 Set Screw, 6mm OD for Cross Connectors |
| 00193082030666 | APEX M6 Set Screw for Lateral Closed, Rod and Tandem Connectors |
| 00193082030659 | APEX Ti Offset Right Hook 9.5mm |
| 00193082030642 | APEX Ti Offset Right Hook 8.0mm |
| 00193082030635 | APEX Ti Offset Right Hook 6.5mm |
| 00193082030628 | APEX Ti Offset Right Hook 5.0mm |
| 00193082030611 | APEX Ti Offset Left Hook 9.5mm |
| 00193082030604 | APEX Ti Offset Left Hook 8.0mm |
| 00193082030598 | APEX Ti Offset Left Hook 6.5mm |
| 00193082030581 | APEX Ti Offset Left Hook 5.0mm |
| 00193082030574 | APEX Ti Wide Laminar Hook 9.5mm |
| 00193082030567 | APEX Ti Wide Laminar Hook 8.0mm |
| 00193082030550 | APEX Ti Wide Laminar Hook 6.5mm |
| 00193082030543 | APEX Ti Wide Laminar Hook 5.0mm |
| 00193082030536 | APEX Ti Bifid Hook 9.5mm |
Trademark Results [APEX Spine System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 APEX SPINE SYSTEM 85820194 not registered Dead/Abandoned |
SpineCraft, LLC 2013-01-10 |
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