The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acumed Anatomic Radial Head System.
| Device ID | K041858 |
| 510k Number | K041858 |
| Device Name: | ACUMED ANATOMIC RADIAL HEAD SYSTEM |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Applicant | ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 -9432 |
| Contact | Ed Boehmer |
| Correspondent | Ed Boehmer ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 -9432 |
| Product Code | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-09 |
| Decision Date | 2004-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10806378085642 | K041858 | 000 |
| 10806378085635 | K041858 | 000 |
| 10806378085628 | K041858 | 000 |
| 10806378085611 | K041858 | 000 |
| 10806378085604 | K041858 | 000 |
| 10806378051173 | K041858 | 000 |
| 10806378051142 | K041858 | 000 |
| 10806378051135 | K041858 | 000 |