The following data is part of a premarket notification filed by Howmedica Osteonics with the FDA for Restoration Acetabular Wedge Augments.
| Device ID | K102019 |
| 510k Number | K102019 |
| Device Name: | RESTORATION ACETABULAR WEDGE AUGMENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | HOWMEDICA OSTEONICS 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS 325 Corporate Drive 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 | 2010-07-19 |
| Decision Date | 2011-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327019872 | K102019 | 000 |
| 07613327019711 | K102019 | 000 |
| 07613327019728 | K102019 | 000 |
| 07613327019735 | K102019 | 000 |
| 07613327019742 | K102019 | 000 |
| 07613327019759 | K102019 | 000 |
| 07613327019766 | K102019 | 000 |
| 07613327019773 | K102019 | 000 |
| 07613327019780 | K102019 | 000 |
| 07613327019797 | K102019 | 000 |
| 07613327019803 | K102019 | 000 |
| 07613327019810 | K102019 | 000 |
| 07613327019827 | K102019 | 000 |
| 07613327019834 | K102019 | 000 |
| 07613327019841 | K102019 | 000 |
| 07613327019858 | K102019 | 000 |
| 07613327019865 | K102019 | 000 |
| 07613327019704 | K102019 | 000 |