Class Class II
INJECTION PIN (KIP(02031-02061) (03031-03061)) (K221697)
Description
INJECTION PIN (KIP(02031-02061) (03031-03061)) by Slk Ortho, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221697
Clearance Date2023-03-03
Clearance TypeTraditional
Product CodeNDN
Regulation Number888.3027
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221697
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. INJECTION PIN (KIP(02031-02061) (03031-03061)) (K221697) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191709 | V-STRUT Vertebral Implant | Hyprevention Sas | 2020 |
| K143596 | MINIARS SCREWS | Overmed Srl. | 2016 |
| K103433 | F20 | Teknimed, S.A. | 2011 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250637 | VCFix Spinal System | Amber Implants | 2025 |
Trace the full predicate network for K221697
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.