The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Tritanium Non-modular Shell & X3 All-poly Insert.
| Device ID | K090897 |
| 510k Number | K090897 |
| Device Name: | TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Avital Merl-margulies |
| Correspondent | Avital Merl-margulies HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-01 |
| Decision Date | 2009-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327026030 | K090897 | 000 |
| 07613327025750 | K090897 | 000 |
| 07613327025767 | K090897 | 000 |
| 07613327025774 | K090897 | 000 |
| 07613327025781 | K090897 | 000 |
| 07613327025798 | K090897 | 000 |
| 07613327025804 | K090897 | 000 |
| 07613327025811 | K090897 | 000 |
| 07613327025828 | K090897 | 000 |
| 07613327025743 | K090897 | 000 |
| 07613327025736 | K090897 | 000 |
| 07613327025644 | K090897 | 000 |
| 07613327025651 | K090897 | 000 |
| 07613327025668 | K090897 | 000 |
| 07613327025675 | K090897 | 000 |
| 07613327025682 | K090897 | 000 |
| 07613327025699 | K090897 | 000 |
| 07613327025705 | K090897 | 000 |
| 07613327025712 | K090897 | 000 |
| 07613327025835 | K090897 | 000 |
| 07613327025842 | K090897 | 000 |
| 07613327025958 | K090897 | 000 |
| 07613327025965 | K090897 | 000 |
| 07613327025972 | K090897 | 000 |
| 07613327025989 | K090897 | 000 |
| 07613327025996 | K090897 | 000 |
| 07613327026009 | K090897 | 000 |
| 07613327026016 | K090897 | 000 |
| 07613327026023 | K090897 | 000 |
| 07613327025941 | K090897 | 000 |
| 07613327025934 | K090897 | 000 |
| 07613327025859 | K090897 | 000 |
| 07613327025866 | K090897 | 000 |
| 07613327025873 | K090897 | 000 |
| 07613327025880 | K090897 | 000 |
| 07613327025897 | K090897 | 000 |
| 07613327025903 | K090897 | 000 |
| 07613327025910 | K090897 | 000 |
| 07613327025927 | K090897 | 000 |
| 07613327025620 | K090897 | 000 |