The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Titanium Hip 1019.
Device ID | K843909 |
510k Number | K843909 |
Device Name: | TITANIUM HIP 1019 |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | DEPUY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Contact | Stephen M Doyle |
Correspondent | Stephen M Doyle DEPUY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-03 |
Decision Date | 1984-11-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10603295033196 | K843909 | 000 |
10603295033189 | K843909 | 000 |
10603295033172 | K843909 | 000 |
10603295033110 | K843909 | 000 |
10603295033103 | K843909 | 000 |
10603295033097 | K843909 | 000 |
10603295033080 | K843909 | 000 |
10603295033073 | K843909 | 000 |
10603295033066 | K843909 | 000 |