The following data is part of a premarket notification filed by Ortho Solutions Uk Limited with the FDA for Orthosolutions 'system26' Bone Screws.
Device ID | K163489 |
510k Number | K163489 |
Device Name: | OrthoSolutions 'System26' Bone Screws |
Classification | Screw, Fixation, Bone |
Applicant | Ortho SOlutions UK Limited West Station Business Park, Spital Road Maldon, GB Cm9 6ff |
Contact | Craig Bluett |
Correspondent | Al Lippincott Engineering Consulting Services, Inc. 3150 E. 200th St. Prior Lake, MN 55372 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-12 |
Decision Date | 2017-03-08 |
Summary: | summary |