BI-MENTUM™ ALTRX® Dual Mobility Liner
Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Depuy Ireland UC
The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Bi-mentum™ Altrx® Dual Mobility Liner.
Pre-market Notification Details
| Device ID | K203532 |
| 510k Number | K203532 |
| Device Name: | BI-MENTUM™ ALTRX® Dual Mobility Liner |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Depuy Ireland UC Loughbeg Ringaskiddy Co. Cork, IE |
| Contact | Erin Combs |
| Correspondent | Floriane Heinrich Depuy Ireland UC Loughbeg Ringaskiddy Co. Cork, IE |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-02 |
| Decision Date | 2021-04-28 |
Trademark Results [BI-MENTUM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BI-MENTUM 87672999 not registered Live/Pending |
Depuy Synthes, Inc. 2017-11-06 |
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