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 |