The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Acumed Modular Shoulder System.
| Device ID | K992525 |
| 510k Number | K992525 |
| Device Name: | ACUMED MODULAR SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Contact | Shari Jeffers |
| Correspondent | Shari Jeffers ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-28 |
| Decision Date | 2000-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10806378084683 | K992525 | 000 |
| 10806378084317 | K992525 | 000 |
| 10806378084300 | K992525 | 000 |
| 10806378083679 | K992525 | 000 |
| 10806378083662 | K992525 | 000 |
| 10806378083631 | K992525 | 000 |
| 10806378083624 | K992525 | 000 |
| 10806378083532 | K992525 | 000 |
| 10806378083440 | K992525 | 000 |
| 10806378083358 | K992525 | 000 |
| 10806378084386 | K992525 | 000 |
| 10806378084393 | K992525 | 000 |
| 10806378084461 | K992525 | 000 |
| 10806378084676 | K992525 | 000 |
| 10806378083716 | K992525 | 000 |
| 10806378083709 | K992525 | 000 |
| 10806378082610 | K992525 | 000 |
| 10806378082603 | K992525 | 000 |
| 10806378084522 | K992525 | 000 |
| 10806378084515 | K992525 | 000 |
| 10806378084485 | K992525 | 000 |
| 10806378084478 | K992525 | 000 |
| 10806378083174 | K992525 | 000 |