DEVICE: Divergence® Anterior Cervical Fusion System (00643169337220)
Device Identifier (DI) Information
Divergence® Anterior Cervical Fusion System
G7730240
Not in Commercial Distribution
MEDTRONIC SOFAMOR DANEK, INC.
G7730240
Not in Commercial Distribution
MEDTRONIC SOFAMOR DANEK, INC.
IMPLANT G7730240 MP PARAL 10MMX20MMX14MM
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ODP | Intervertebral fusion device with bone graft, cervical |
KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K140417 | 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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Depth: 11.4 Millimeter |
Height: 10.0 Millimeter |
Width: 20.0 Millimeter |
Angle: 0.0 degree |
Device Record Status
b66f004a-9c9b-45a6-abc8-9230bf837a80
September 11, 2024
9
April 14, 2016
September 11, 2024
9
April 14, 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 |
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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
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com