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 |