The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Modified Aml + Acetabular Cup Prosthesis.
Device ID | K900891 |
510k Number | K900891 |
Device Name: | MODIFIED AML + ACETABULAR CUP PROSTHESIS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
Contact | Kenneth G Roberts |
Correspondent | Kenneth G Roberts DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-27 |
Decision Date | 1990-03-12 |