The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Tritanium Acetabular Shell System.
| Device ID | K081171 |
| 510k Number | K081171 |
| Device Name: | TRITANIUM ACETABULAR SHELL SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Kimberly Lane |
| Correspondent | Kimberly Lane HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-24 |
| Decision Date | 2008-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327040081 | K081171 | 000 |
| 07613327039986 | K081171 | 000 |
| 07613327039993 | K081171 | 000 |
| 07613327040005 | K081171 | 000 |
| 07613327040012 | K081171 | 000 |
| 07613327040029 | K081171 | 000 |
| 07613327040036 | K081171 | 000 |
| 07613327040043 | K081171 | 000 |
| 07613327040050 | K081171 | 000 |
| 07613327040067 | K081171 | 000 |
| 07613327040074 | K081171 | 000 |
| 07613327039979 | K081171 | 000 |