The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Standard Porocoat Modified Medial Aspect Aml Hip.
Device ID | K870699 |
510k Number | K870699 |
Device Name: | STANDARD POROCOAT MODIFIED MEDIAL ASPECT AML HIP |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
Contact | Steven J Wentworth |
Correspondent | Steven J Wentworth DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-19 |
Decision Date | 1987-05-01 |