The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Bias(tm) Fiber Metal Total Hip Stem (tfb).
| Device ID | K934515 |
| 510k Number | K934515 |
| Device Name: | BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Max Sherman |
| Correspondent | Max Sherman ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-15 |
| Decision Date | 1995-03-07 |