DEVICE: Inertia® Pedicle Screw System (00889929005644)
Device Identifier (DI) Information
Inertia® Pedicle Screw System
10-22-4530
In Commercial Distribution
NEXXT SPINE, LLC
10-22-4530
In Commercial Distribution
NEXXT SPINE, LLC
MAC Pedicle Screw, Ø4.5x30mm
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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 |
---|---|
KWP | Appliance, Fixation, Spinal Interlaminal |
MNI | Orthosis, Spinal Pedicle Fixation |
MNH | Orthosis, Spondylolisthesis Spinal Fixation |
OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
NKB | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K101278 | 000 |
K153453 | 000 |
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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Outer Diameter: 4.5 Millimeter |
Length: 30 Millimeter |
Device Size Text, specify: Friction |
Device Record Status
41bddbda-ae70-4dd7-ae10-e4faedef06b3
September 11, 2024
5
September 08, 2015
September 11, 2024
5
September 08, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
317-436-7801
Support@nexxtspine.com
Support@nexxtspine.com