The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acumed Small Bone Locking Rod System Ii.
| Device ID | K031438 |
| 510k Number | K031438 |
| Device Name: | ACUMED SMALL BONE LOCKING ROD SYSTEM II |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| 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 | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-06 |
| Decision Date | 2003-07-17 |
| Summary: | summary |