The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Accolade Tmzf Plus Ha 127 Size 0 Hip Stem.
| Device ID | K023102 |
| 510k Number | K023102 |
| Device Name: | ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM |
| 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 | Debra Bing |
| Correspondent | Debra Bing HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-18 |
| Decision Date | 2002-10-09 |
| Summary: | summary |