The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Modular Replacement Elbow System.
| Device ID | K062845 |
| 510k Number | K062845 |
| Device Name: | MODULAR REPLACEMENT ELBOW SYSTEM |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Francisco Haro |
| Correspondent | Francisco Haro HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-22 |
| Decision Date | 2006-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327139303 | K062845 | 000 |
| 07613327138412 | K062845 | 000 |
| 07613327138450 | K062845 | 000 |
| 07613327138467 | K062845 | 000 |
| 07613327138474 | K062845 | 000 |
| 07613327138481 | K062845 | 000 |
| 07613327138498 | K062845 | 000 |
| 07613327139167 | K062845 | 000 |
| 07613327139181 | K062845 | 000 |
| 07613327139198 | K062845 | 000 |
| 07613327139204 | K062845 | 000 |
| 07613327139211 | K062845 | 000 |
| 07613327139266 | K062845 | 000 |
| 07613327138221 | K062845 | 000 |