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 |
| 10603295033219 | K843909 | 000 |
| 10603295033066 | K843909 | 000 |
| 10603295033073 | K843909 | 000 |
| 10603295033080 | K843909 | 000 |
| 10603295033097 | K843909 | 000 |
| 10603295033103 | K843909 | 000 |
| 10603295033110 | K843909 | 000 |
| 10603295033172 | K843909 | 000 |
| 10603295033189 | K843909 | 000 |
| 10603295033134 | K843909 | 000 |