DEVICE: Simplify® Cervical Artificial Disc (00843285100139)
Device Identifier (DI) Information
Simplify® Cervical Artificial Disc
A
In Commercial Distribution
LG-6L
Nuvasive, Inc.
A
In Commercial Distribution
LG-6L
Nuvasive, Inc.
Simplify® Cervical Artificial Disc Size LG, Height 6, 5° Lordosis
Device Characteristics
MR Conditional | |
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? |
---|---|---|---|---|
48164 | Cervical total intervertebral disc prosthesis, modular |
An implantable three-component assembly of devices intended to replace a dysfunctional intervertebral disc in the cervical spine that is comprised of an upper and lower endplate for attachment to adjacent vertebrae, and a space-occupying core between the plates to allow small movements of the adjacent vertebrae. The endplates are typically made of metal, and the core ceramic or synthetic polymer materials.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MJO | Prosthesis, Intervertebral Disc |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P200022 | 002 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Height: 6 Millimeter |
Angle: 5 degree |
Device Record Status
190f964f-49df-4977-a4c8-794d9b00330e
February 04, 2022
4
December 14, 2020
February 04, 2022
4
December 14, 2020
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(858)909-1800
RA_UDI@nuvasive.com
RA_UDI@nuvasive.com