DEVICE: Vital MIS Spinal Fixation System (03662663238366)
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Device Identifier (DI) Information
Vital MIS Spinal Fixation System
825M8075
In Commercial Distribution
825M8075
Highridge Medical, LLC
825M8075
In Commercial Distribution
825M8075
Highridge Medical, LLC
Ø8.0x75mm Cannulated Polyaxial Extended Tab Screw
Device Characteristics
| MR Conditional | |
| No | |
| No | |
| No | |
| No | |
| 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 |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
08a28c36-c5a3-4676-85ac-d1a0c19c13f0
December 26, 2025
1
December 18, 2025
December 26, 2025
1
December 18, 2025
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(800)447-3625
usbrocustomerservice@highridgemedical.com
usbrocustomerservice@highridgemedical.com