The following data is part of a premarket notification filed by In2bonesusa, Llc with the FDA for In2bones Fracture And Correction System.
Device ID | K170518 |
510k Number | K170518 |
Device Name: | In2Bones Fracture And Correction System |
Classification | Plate, Fixation, Bone |
Applicant | In2BonesUSA, LLC 6060 Poplar Ave, Suite 380 Memphis, TN 38119 |
Contact | Joe Clift |
Correspondent | Christine Scifert MRC-X, LLC 6075 Poplar Avenue Suite 500 Memphis, TN 38119 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-21 |
Decision Date | 2017-07-14 |
Summary: | summary |