The following data is part of a premarket notification filed by Plus Orthopedics Ag with the FDA for Promos Modular Shoulder System.
| Device ID | K063578 |
| 510k Number | K063578 |
| Device Name: | PROMOS MODULAR SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | PLUS ORTHOPEDICS AG 18 BRIDIE LANE Norfolk, MA 02056 |
| Contact | Pamela J Weagraff |
| Correspondent | Pamela J Weagraff PLUS ORTHOPEDICS AG 18 BRIDIE LANE Norfolk, MA 02056 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-30 |
| Decision Date | 2007-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611996086812 | K063578 | 000 |
| 07611996076981 | K063578 | 000 |
| 07611996083620 | K063578 | 000 |
| 07611996083637 | K063578 | 000 |
| 07611996083644 | K063578 | 000 |
| 07611996083835 | K063578 | 000 |
| 07611996083842 | K063578 | 000 |
| 07611996083859 | K063578 | 000 |
| 07611996086805 | K063578 | 000 |
| 07611996076974 | K063578 | 000 |