The following data is part of a premarket notification filed by Acumed Llc with the FDA for Frag-loc System.
| Device ID | K130986 |
| 510k Number | K130986 |
| Device Name: | FRAG-LOC SYSTEM |
| Classification | Washer, Bolt Nut |
| Applicant | ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 -9432 |
| Contact | Kara Budor |
| Correspondent | Kara Budor ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 -9432 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-09 |
| Decision Date | 2013-07-23 |
| Summary: | summary |