The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Modular Dual Mobility Liner, X3 Acetabular Insert.
| Device ID | K103233 |
| 510k Number | K103233 |
| Device Name: | MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Avital Merl-margulies |
| Correspondent | Avital Merl-margulies HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-02 |
| Decision Date | 2011-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540666062 | K103233 | 000 |
| 04546540665898 | K103233 | 000 |
| 04546540665997 | K103233 | 000 |
| 04546540666000 | K103233 | 000 |
| 04546540666017 | K103233 | 000 |
| 04546540666024 | K103233 | 000 |
| 04546540666031 | K103233 | 000 |
| 04546540666048 | K103233 | 000 |
| 04546540666055 | K103233 | 000 |
| 04546540665881 | K103233 | 000 |