The following data is part of a premarket notification filed by Centerplus Orthopedics, Inc with the FDA for Amatomical Shoulder With Removable Head.
| Device ID | K030259 |
| 510k Number | K030259 |
| Device Name: | AMATOMICAL SHOULDER WITH REMOVABLE HEAD |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | CENTERPLUS ORTHOPEDICS, INC 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Audrey Swearingen |
| Correspondent | Audrey Swearingen CENTERPLUS ORTHOPEDICS, INC 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-24 |
| Decision Date | 2003-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024286245 | K030259 | 000 |
| 00889024285576 | K030259 | 000 |
| 00889024285583 | K030259 | 000 |
| 00889024285590 | K030259 | 000 |
| 00889024285606 | K030259 | 000 |
| 00889024285699 | K030259 | 000 |
| 00889024285705 | K030259 | 000 |
| 00889024285712 | K030259 | 000 |
| 00889024285729 | K030259 | 000 |
| 00889024285897 | K030259 | 000 |
| 00889024285903 | K030259 | 000 |
| 00889024285910 | K030259 | 000 |
| 00889024285927 | K030259 | 000 |
| 00889024285569 | K030259 | 000 |