The following data is part of a premarket notification filed by Orthopedic Sciences, Inc with the FDA for Modification To Titanium Shoulder Plate Implant.
| Device ID | K063033 |
| 510k Number | K063033 |
| Device Name: | MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT |
| Classification | Plate, Fixation, Bone |
| Applicant | ORTHOPEDIC SCIENCES, INC 3020 OLD RANCH PARKWAY SUITE 325 Seal Beach, CA 90740 |
| Contact | James Brannon M.d. |
| Correspondent | James Brannon M.d. ORTHOPEDIC SCIENCES, INC 3020 OLD RANCH PARKWAY SUITE 325 Seal Beach, CA 90740 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-03 |
| Decision Date | 2006-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813892020762 | K063033 | 000 |
| 00813892020540 | K063033 | 000 |
| 00813892020687 | K063033 | 000 |
| 00813892020694 | K063033 | 000 |
| 00813892020700 | K063033 | 000 |
| 00813892020717 | K063033 | 000 |
| 00813892020724 | K063033 | 000 |
| 00813892020731 | K063033 | 000 |
| 00813892020748 | K063033 | 000 |
| 00813892020755 | K063033 | 000 |
| 00813892020533 | K063033 | 000 |