The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Accolade-j Hip Stem Series.
Device ID | K032300 |
510k Number | K032300 |
Device Name: | ACCOLADE-J HIP STEM SERIES |
Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Contact | Lorraine Montemurro |
Correspondent | Lorraine Montemurro HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Product Code | MEH |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-25 |
Decision Date | 2003-10-09 |
Summary: | summary |