The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Howmedica Osteonics Restoration Ha Hip Stem.
| Device ID | K993077 |
| 510k Number | K993077 |
| Device Name: | HOWMEDICA OSTEONICS RESTORATION HA HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Mary-catherine Dillon |
| Correspondent | Mary-catherine Dillon HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-14 |
| Decision Date | 1999-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327019001 | K993077 | 000 |
| 07613327018851 | K993077 | 000 |
| 07613327018844 | K993077 | 000 |
| 07613327018837 | K993077 | 000 |
| 07613327018820 | K993077 | 000 |
| 07613327018813 | K993077 | 000 |
| 07613327018806 | K993077 | 000 |
| 07613327018790 | K993077 | 000 |
| 07613327018783 | K993077 | 000 |
| 07613327018776 | K993077 | 000 |
| 07613327018769 | K993077 | 000 |
| 07613327018752 | K993077 | 000 |
| 07613327018745 | K993077 | 000 |
| 07613327018868 | K993077 | 000 |
| 07613327018875 | K993077 | 000 |
| 07613327018998 | K993077 | 000 |
| 07613327018981 | K993077 | 000 |
| 07613327018974 | K993077 | 000 |
| 07613327018967 | K993077 | 000 |
| 07613327018950 | K993077 | 000 |
| 07613327018943 | K993077 | 000 |
| 07613327018936 | K993077 | 000 |
| 07613327018929 | K993077 | 000 |
| 07613327018912 | K993077 | 000 |
| 07613327018905 | K993077 | 000 |
| 07613327018899 | K993077 | 000 |
| 07613327018882 | K993077 | 000 |
| 07613327018738 | K993077 | 000 |