The following data is part of a premarket notification filed by Flower Orthopedics Corporation with the FDA for Flower Bone Screw Set.
Device ID | K170687 |
510k Number | K170687 |
Device Name: | Flower Bone Screw Set |
Classification | Screw, Fixation, Bone |
Applicant | Flower Orthopedics Corporation 100 Witmer Road. Suite 280 Horsham, PA 19044 |
Contact | Jessica Huang |
Correspondent | Jessica Huang Flower Orthopedics Corporation 100 Witmer Road. Suite 280 Horsham, PA 19044 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-07 |
Decision Date | 2017-06-06 |
Summary: | summary |