The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for 2 Piece Modular Hip Stem.
| Device ID | K013106 |
| 510k Number | K013106 |
| Device Name: | 2 PIECE MODULAR HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Williamr J Cymbaluk |
| Correspondent | Williamr J Cymbaluk HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-17 |
| Decision Date | 2002-04-03 |
| Summary: | summary |