The following data is part of a premarket notification filed by Ascent Medical, Llc with the FDA for Phin-fx Cannulated Lag Screw System.
| Device ID | K150693 |
| 510k Number | K150693 |
| Device Name: | PHIN-FX Cannulated Lag Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | ASCENT MEDICAL, LLC 47801-I-55 NORTH, SUITE 100 Jackson, MS 39211 |
| Contact | David Ford |
| Correspondent | Al Lippincott ENGINEERING CONSULTING SERVICES, INC. 3150 E. 200TH. ST. Prior Lake, MN 55372 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-18 |
| Decision Date | 2015-10-13 |
| Summary: | summary |