DEVICE: Valencia Pedicle Screw System (B41799065251)
Device Identifier (DI) Information
Valencia Pedicle Screw System
990-6525
In Commercial Distribution
Altus Spine, LLC
990-6525
In Commercial Distribution
Altus Spine, LLC
6.5mm x 25mm Dual Lead Closed Head Screw
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
No | |
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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.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
MNH | Orthosis, spondylolisthesis spinal fixation |
MNI | ORTHOSIS, SPINAL PEDICLE FIXATION |
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 25 Millimeter |
Outer Diameter: 6.5 Millimeter |
Device Record Status
50cd888b-5d0e-45d0-b0d2-7854096adc45
September 11, 2024
4
October 28, 2016
September 11, 2024
4
October 28, 2016
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 |
---|---|
GS1 | 00843210116983 |
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(610)355-4156
Info@altus-spine.com
Info@altus-spine.com