The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Beta Hip Prosthesis.
Device ID | K953337 |
510k Number | K953337 |
Device Name: | BETA HIP PROSTHESIS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Angie Ide |
Correspondent | Angie Ide 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 | 1995-07-17 |
Decision Date | 1996-01-22 |