The following data is part of a premarket notification filed by Acumed, Llc with the FDA for Acumed Small Bone Im Nail System.
| Device ID | K143276 |
| 510k Number | K143276 |
| Device Name: | Acumed Small Bone IM Nail System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Acumed, LLC 5885 NW Cornelius Pass Road Hillsboro, OR 97124 |
| Contact | Nathan Wolf |
| Correspondent | Nathan Wolf Acumed, LLC 5885 NW Cornelius Pass Road Hillsboro, OR 97124 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-14 |
| Decision Date | 2015-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10806378098529 | K143276 | 000 |
| 10806378079535 | K143276 | 000 |
| 10806378110757 | K143276 | 000 |
| 10806378110740 | K143276 | 000 |
| 10806378110733 | K143276 | 000 |
| 10806378110726 | K143276 | 000 |
| 10806378110719 | K143276 | 000 |
| 10806378110702 | K143276 | 000 |
| 10806378099168 | K143276 | 000 |
| 10806378099144 | K143276 | 000 |
| 10806378099120 | K143276 | 000 |
| 10806378099106 | K143276 | 000 |
| 10806378099083 | K143276 | 000 |
| 10806378097683 | K143276 | 000 |
| 10806378097720 | K143276 | 000 |
| 10806378098505 | K143276 | 000 |
| 10806378098482 | K143276 | 000 |
| 10806378098468 | K143276 | 000 |
| 10806378098444 | K143276 | 000 |
| 10806378098420 | K143276 | 000 |
| 10806378098352 | K143276 | 000 |
| 10806378098345 | K143276 | 000 |
| 10806378098277 | K143276 | 000 |
| 10806378098215 | K143276 | 000 |
| 10806378098161 | K143276 | 000 |
| 10806378097751 | K143276 | 000 |
| 10806378097744 | K143276 | 000 |
| 10806378099069 | K143276 | 000 |