The following data is part of a premarket notification filed by Flower Orthopedics Corporation with the FDA for Flower Small And Medium Implant Set.
Device ID | K131657 |
510k Number | K131657 |
Device Name: | FLOWER SMALL AND MEDIUM IMPLANT SET |
Classification | Plate, Fixation, Bone |
Applicant | FLOWER ORTHOPEDICS CORPORATION 1835 MARKET ST, 29TH FLOOR Philadelphia, PA 19103 |
Contact | Janice M Hogan |
Correspondent | Janice M Hogan FLOWER ORTHOPEDICS CORPORATION 1835 MARKET ST, 29TH FLOOR Philadelphia, PA 19103 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-06-06 |
Decision Date | 2013-08-22 |
Summary: | summary |