The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Restoration Adm System X3 Acetabular.
| Device ID | K093644 |
| 510k Number | K093644 |
| Device Name: | RESTORATION ADM SYSTEM X3 ACETABULAR |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Avital Merl Margulies |
| Correspondent | Avital Merl Margulies HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-25 |
| Decision Date | 2009-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540665904 | K093644 | 000 |
| 04546540638984 | K093644 | 000 |
| 04546540638991 | K093644 | 000 |
| 04546540639004 | K093644 | 000 |
| 04546540639011 | K093644 | 000 |
| 04546540639028 | K093644 | 000 |
| 04546540639035 | K093644 | 000 |
| 04546540639042 | K093644 | 000 |
| 04546540639059 | K093644 | 000 |
| 04546540638977 | K093644 | 000 |