The following data is part of a premarket notification filed by Agent Medical, Llc with the FDA for Anthrobridge-screw 25,30,35,40,45,50mm; Anthrobridge- Proximal Module 4.0,4.5,5.0mm.
| Device ID | K142528 |
| 510k Number | K142528 |
| Device Name: | AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm |
| Classification | Screw, Fixation, Bone |
| Applicant | Agent Medical, LLC 1145 Gaskins Road, Suite 102 Richmond, VA 23238 |
| Contact | Scott Munday |
| 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 | 2014-09-09 |
| Decision Date | 2014-12-22 |
| Summary: | summary |