DEVICE: APEX Spine System (00193082024917)
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If so, send a picture of the label to
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Device Identifier (DI) Information
APEX Spine System
UF6-6250
In Commercial Distribution
UF6-6250
SPINECRAFT, LLC
UF6-6250
In Commercial Distribution
UF6-6250
SPINECRAFT, LLC
APEX Ti Uniplanar Screw, Dia.6.25x 50mm, Self-Tapping
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| Yes | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 46651 | Spinal bone screw, non-bioabsorbable |
A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
| NKB | Thoracolumbosacral pedicle screw system |
| KWQ | Appliance, fixation, spinal intervertebral body |
| MNI | Orthosis, spinal pedicle fixation |
| MNH | Orthosis, spondylolisthesis spinal fixation |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K132603 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
06cec8ce-52c0-41df-b43a-538200ebc9de
September 11, 2024
3
March 25, 2019
September 11, 2024
3
March 25, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(630)920-7300
info@spinecraft.com
info@spinecraft.com