The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Secur-fit Ha And Secur-fit Plus Hip Stems.
| Device ID | K041170 |
| 510k Number | K041170 |
| Device Name: | SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-04 |
| Decision Date | 2004-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327021165 | K041170 | 000 |
| 07613327020953 | K041170 | 000 |
| 07613327020946 | K041170 | 000 |
| 07613327020939 | K041170 | 000 |
| 07613327020922 | K041170 | 000 |
| 07613327020915 | K041170 | 000 |
| 07613327020908 | K041170 | 000 |
| 07613327020892 | K041170 | 000 |
| 07613327020885 | K041170 | 000 |
| 07613327020878 | K041170 | 000 |
| 07613327020861 | K041170 | 000 |
| 07613327020854 | K041170 | 000 |
| 07613327020847 | K041170 | 000 |
| 07613327020830 | K041170 | 000 |
| 07613327020823 | K041170 | 000 |
| 07613327020816 | K041170 | 000 |
| 07613327020809 | K041170 | 000 |
| 07613327020793 | K041170 | 000 |
| 07613327020960 | K041170 | 000 |
| 07613327020977 | K041170 | 000 |
| 07613327020984 | K041170 | 000 |
| 07613327021158 | K041170 | 000 |
| 07613327021141 | K041170 | 000 |
| 07613327021134 | K041170 | 000 |
| 07613327021127 | K041170 | 000 |
| 07613327021110 | K041170 | 000 |
| 07613327021103 | K041170 | 000 |
| 07613327021097 | K041170 | 000 |
| 07613327021080 | K041170 | 000 |
| 07613327021073 | K041170 | 000 |
| 07613327021066 | K041170 | 000 |
| 07613327021059 | K041170 | 000 |
| 07613327021042 | K041170 | 000 |
| 07613327021035 | K041170 | 000 |
| 07613327021028 | K041170 | 000 |
| 07613327021011 | K041170 | 000 |
| 07613327021004 | K041170 | 000 |
| 07613327020991 | K041170 | 000 |
| 07613327020786 | K041170 | 000 |