The following data is part of a premarket notification filed by Fusion Orthopedics, Llc with the FDA for Fuzefix Screw System.
| Device ID | K170038 |
| 510k Number | K170038 |
| Device Name: | FuzeFix Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | Fusion Orthopedics, LLC 4135 S. Power Rd. Suite 110 Mesa, AZ 85212 |
| Contact | Adam Cundiff |
| Correspondent | J. D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd. Round Rock, TX 78681 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-05 |
| Decision Date | 2017-08-07 |
| Summary: | summary |