The following data is part of a premarket notification filed by Acumed, Llc with the FDA for Acumed Hand Fracture System.
| Device ID | K141383 |
| 510k Number | K141383 |
| Device Name: | ACUMED HAND FRACTURE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | ACUMED, LLC 5885 NW CORNELIUS PASS ROAD Hillsboro, OR 97124 |
| Contact | Mariah Knight |
| Correspondent | Mariah Knight ACUMED, LLC 5885 NW CORNELIUS PASS ROAD Hillsboro, OR 97124 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-27 |
| Decision Date | 2014-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10806378096457 | K141383 | 000 |
| 10806378021886 | K141383 | 000 |
| 10806378022265 | K141383 | 000 |
| 10806378022159 | K141383 | 000 |
| 10806378022203 | K141383 | 000 |
| 10806378051753 | K141383 | 000 |
| 10806378051760 | K141383 | 000 |
| 10806378051784 | K141383 | 000 |
| 10806378052842 | K141383 | 000 |
| 10806378052859 | K141383 | 000 |
| 10806378095016 | K141383 | 000 |
| 10806378095023 | K141383 | 000 |
| 10806378095399 | K141383 | 000 |
| 10806378095405 | K141383 | 000 |
| 10806378021824 | K141383 | 000 |