The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Depuy Pinnacle Dual Mobility Liner.
| Device ID | K200854 |
| 510k Number | K200854 |
| Device Name: | DePuy PINNACLE Dual Mobility Liner |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DePuy Ireland UC Loughbeg Ringaskiddy Co. Cork, IE |
| Contact | Erin Combs |
| Correspondent | Melissa Cook DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46582 |
| Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-31 |
| Decision Date | 2020-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295520344 | K200854 | 000 |
| 10603295520184 | K200854 | 000 |
| 10603295520276 | K200854 | 000 |
| 10603295520283 | K200854 | 000 |
| 10603295520290 | K200854 | 000 |
| 10603295520306 | K200854 | 000 |
| 10603295520313 | K200854 | 000 |
| 10603295520320 | K200854 | 000 |
| 10603295520337 | K200854 | 000 |
| 10603295520177 | K200854 | 000 |