The following data is part of a premarket notification filed by Acumed, Llc with the FDA for Acumed Suture Anchor System.
| Device ID | K140925 |
| 510k Number | K140925 |
| Device Name: | ACUMED SUTURE ANCHOR SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ACUMED, LLC 5885 NW CORNELIUS PASS ROAD Hillsboro, OR 97124 |
| Contact | Lino Tsai |
| Correspondent | Lino Tsai ACUMED, LLC 5885 NW CORNELIUS PASS ROAD Hillsboro, OR 97124 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-11 |
| Decision Date | 2014-05-20 |
| Summary: | summary |