ProDisc PDL-L-IP00S
ProDisc PDL-L-IP00S (PDLLIP00S) is a Class III device made by Synthes (U.S.a.) LP, approved under FDA PMA P050010 on 14 Aug 2006 and listed in FDA GUDID since 17 Feb 2017 (UDI-DI 10705034700014), active as of 23 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10705034700014 | Date17 Feb 2017 | StatusListed |
| United States | FDA PMAAPPR | NumberP050010 | Date14 Aug 2006 | StatusActive |
Official records
- AccessGUDID record 10705034700014
- FDA PMA database P050010
Across registries
- FDA PMA P050010 decided 14 Aug 2006 Active
- FDA GUDID UDI-DI 10705034700014 listed 17 Feb 2017 Listed
Timeline
- Approved FDA PMA P050010
- Listed FDA GUDID 10705034700014
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- ProDisc
- Generic name
- Lumbar total intervertebral disc prosthesis
- Model / Ref / Catalog
- PDL-L-IP00S, PDLLIP00S
- Primary DI / UDI-DI
- 10705034700014
- PMA number
- FDA product code
- MJO
- GMDN term
- Lumbar total intervertebral disc prosthesis
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices
Other devices filed under FDA product code MJO (PROSTHESIS, INTERVERTEBRAL DISC).
- PCM Cervical Disc System by Nuvasive, Inc.
- ACTIVL Artificial Disc by Highridge Medical, LLC.
- Prestige Cervical Disc by MEDTRONIC SOFAMOR DANEK, INC.
- Bryan Cervical Disc Prosthesis by Companion Spine France SAS
- BAGUERA®C Cervical Disc Prosthesis by Spineart USA, Inc.
- SECURE-C Cervical Artificial Disc by GLOBUS MEDICAL, INC.
- Charite Artificial Disc by Depuy Spine, Inc.
- M6-C Artificial Cervical Disc by Spinal Kinetics, LLC
- SECURE-C 414.308S by GLOBUS MEDICAL, INC.
- LDR Spine Mobi-C Cervical Disc Prosthesis (Two Level) by Highridge Medical, LLC.