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.
00643169337220
GS1
September 26, 2022
1
830350380 *Terms of Use
IMPLANT G7730240 MP PARAL 10MMX20MMX14MM
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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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
ODP Intervertebral fusion device with bone graft, cervical
KWQ APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K140417 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Depth: 11.4 Millimeter
Height: 10.0 Millimeter
Width: 20.0 Millimeter
Angle: 0.0 degree
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Device Record Status

b66f004a-9c9b-45a6-abc8-9230bf837a80
September 11, 2024
9
April 14, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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