Class Class II
Haymaker® Screw System (K222799)
Description
Haymaker® Screw System by Orthocircle Spine D.B.A. OC Medical Devices, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222799
Clearance Date2023-01-10
Clearance TypeTraditional
Product CodeHWC
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222799
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Haymaker® Screw System (K222799) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K183603 | INnate Cannulated Screw System | Exsomed Corporation | 2019 |
| K172617 | Treace Medical Concepts (TMC) Compression Screw System | Treace Medical Concepts, Inc. | 2017 |
| K171558 | ExsoMed ITN Cannulated Screw System | Exsomed Holdings Company, LLC | 2017 |
Trace the full predicate network for K222799
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.