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 |