DEVICE: ProDisc-C (10705034763835)
Device Identifier (DI) Information
ProDisc-C
09.820.057S
In Commercial Distribution
09820057S
SYNTHES (U.S.A.) LP
09.820.057S
In Commercial Distribution
09820057S
SYNTHES (U.S.A.) LP
PRODISC-C IMPLANT LARGE DEEP 7MM-STERILE
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 [?] |
---|---|
P070001 | 011 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
7af304a9-ba57-4cfe-ba28-be31a0854bb4
April 21, 2021
6
September 08, 2014
April 21, 2021
6
September 08, 2014
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 |
---|---|
HIBCC | H98109820057S06 |
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)255-2500
xx@xx.xx
xx@xx.xx