The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acumed Clavicle Screw System.
| Device ID | K083144 |
| 510k Number | K083144 |
| Device Name: | ACUMED CLAVICLE SCREW SYSTEM |
| Classification | Pin, Fixation, Threaded |
| Applicant | ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 |
| Contact | Alyssa Thomas |
| Correspondent | Alyssa Thomas ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-23 |
| Decision Date | 2009-06-16 |
| Summary: | summary |