The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Promos Shoulder.
| Device ID | K032126 |
| 510k Number | K032126 |
| Device Name: | PROMOS SHOULDER |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | PLUS ORTHOPEDICS 1001 OAKWOOD BLVD. Round Rock, TX 78681 -2700 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb PLUS ORTHOPEDICS 1001 OAKWOOD BLVD. Round Rock, TX 78681 -2700 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-10 |
| Decision Date | 2004-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611996084368 | K032126 | 000 |
| 07611996037760 | K032126 | 000 |
| 07611996037265 | K032126 | 000 |
| 07611996037258 | K032126 | 000 |
| 07611996037241 | K032126 | 000 |
| 07611996037234 | K032126 | 000 |
| 07611996037227 | K032126 | 000 |
| 07611996037210 | K032126 | 000 |
| 07611996037203 | K032126 | 000 |
| 07611996037197 | K032126 | 000 |
| 07611996037180 | K032126 | 000 |
| 07611996037173 | K032126 | 000 |
| 07611996037166 | K032126 | 000 |
| 07611996037777 | K032126 | 000 |
| 07611996037784 | K032126 | 000 |
| 07611996037791 | K032126 | 000 |
| 07611996084351 | K032126 | 000 |
| 07611996084344 | K032126 | 000 |
| 07611996059571 | K032126 | 000 |
| 07611996059564 | K032126 | 000 |
| 07611996059557 | K032126 | 000 |
| 07611996059540 | K032126 | 000 |
| 07611996059533 | K032126 | 000 |
| 07611996059526 | K032126 | 000 |
| 07611996037838 | K032126 | 000 |
| 07611996037821 | K032126 | 000 |
| 07611996037814 | K032126 | 000 |
| 07611996037807 | K032126 | 000 |
| 07611996037159 | K032126 | 000 |