The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Inhancetm Hybrid Anatomic Glenoid Implant.
| Device ID | K212933 |
| 510k Number | K212933 |
| Device Name: | INHANCETM Hybrid Anatomic Glenoid Implant |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| 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 | MBF |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | PAO |
| CFR Regulation Number | 888.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-15 |
| Decision Date | 2022-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295549185 | K212933 | 000 |
| 10603295549178 | K212933 | 000 |
| 10603295549161 | K212933 | 000 |
| 10603295549154 | K212933 | 000 |
| 10603295549147 | K212933 | 000 |