The following data is part of a premarket notification filed by Fusion Orthopedics, Llc with the FDA for Polylock Small Bone Plating System.
| Device ID | K192323 |
| 510k Number | K192323 |
| Device Name: | PolyLock Small Bone Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Fusion Orthopedics, LLC 4135 S. Power Rd. Suite 110 Mesa, AZ 85212 |
| Contact | Eli Jacobson |
| Correspondent | Eli Jacobson Fusion Orthopedics, LLC 4135 S. Power Rd. Suite 110 Mesa, AZ 85212 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-27 |
| Decision Date | 2019-11-18 |
| Summary: | summary |