DEVICE: APEX Spine System (00193082030833)
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If so, send a picture of the label to
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Device Identifier (DI) Information
APEX Spine System
6000-T8040
In Commercial Distribution
6000-T8040
SPINECRAFT, LLC
6000-T8040
In Commercial Distribution
6000-T8040
SPINECRAFT, LLC
APEX Tandem Rod Connector Dia.6.00 to Dia.6.00mm- Growing Rod, 40mm
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? |
|---|---|---|---|---|
| 65114 | Bone-screw internal spinal fixation system connector |
An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
| MNH | Orthosis, spondylolisthesis spinal fixation |
| MNI | Orthosis, spinal pedicle fixation |
| NKB | Thoracolumbosacral pedicle screw system |
| KWQ | Appliance, fixation, spinal intervertebral body |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K062513 | 000 |
| K092825 | 000 |
| K102488 | 000 |
| K110906 | 000 |
| 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
75300f99-6859-4e05-9073-e8b4b10ec8cb
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