The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acumed Anatomic Radial Head System, Acumed Anatomic Radial Head Long Stems, Acumed Arh Slide-loc.
| Device ID | K131845 |
| 510k Number | K131845 |
| Device Name: | ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Applicant | ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 -9432 |
| Contact | Kara Budor |
| Correspondent | Kara Budor 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 | 2013-06-21 |
| Decision Date | 2013-09-30 |
| Summary: | summary |