The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Inhancetm Reverse Glenoid Peripheral Posts.
| Device ID | K221467 |
| 510k Number | K221467 |
| Device Name: | INHANCETM Reverse Glenoid Peripheral Posts |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Depuy Ireland UC Loughbeg Ringaskiddy, IE |
| Contact | Yayoi Fujimaki |
| Correspondent | Russ Parrott Ignite Orthopedics LLC 700 Park Avenue Suite F Winona Lake, IN 46590 |
| Product Code | PHX |
| Subsequent Product Code | MBF |
| Subsequent Product Code | PAO |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-20 |
| Decision Date | 2022-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295546955 | K221467 | 000 |
| 10603295546948 | K221467 | 000 |
| 10603295546931 | K221467 | 000 |
| 10603295549666 | K221467 | 000 |