The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acumed Small Fragment Base Set.
| Device ID | K143394 |
| 510k Number | K143394 |
| Device Name: | Acumed Small Fragment Base Set |
| Classification | Plate, Fixation, Bone |
| Applicant | ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 -9432 |
| Contact | Nathan Wolf |
| Correspondent | Nathan Wolf ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 -9432 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-26 |
| Decision Date | 2015-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10806378099571 | K143394 | 000 |
| 10806378099304 | K143394 | 000 |
| 10806378099311 | K143394 | 000 |
| 10806378099328 | K143394 | 000 |
| 10806378099335 | K143394 | 000 |
| 10806378099342 | K143394 | 000 |
| 10806378099359 | K143394 | 000 |
| 10806378099366 | K143394 | 000 |
| 10806378099373 | K143394 | 000 |
| 10806378099380 | K143394 | 000 |
| 10806378099540 | K143394 | 000 |
| 10806378099557 | K143394 | 000 |
| 10806378099564 | K143394 | 000 |
| 10806378098611 | K143394 | 000 |