The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Lcs Femoral Hip Prosthesis.
Device ID | K880269 |
510k Number | K880269 |
Device Name: | LCS FEMORAL HIP PROSTHESIS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
Contact | Barry R Sisson |
Correspondent | Barry R Sisson 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 | 1988-01-21 |
Decision Date | 1988-05-06 |