The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Tmzf Press Fit Ha Stem And Tmzf Press Fit Plus Ha Stem.
| Device ID | K994366 |
| 510k Number | K994366 |
| Device Name: | TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Contact | Nancy J Rieder |
| Correspondent | Nancy J Rieder HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-27 |
| Decision Date | 2000-03-16 |
| Summary: | summary |