Class Class II
Dyna Locking Trochanteric Nail™ (K221084)
Description
Dyna Locking Trochanteric Nail™ by Innosys, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221084
Clearance Date2023-03-03
Clearance TypeSpecial
Product CodeHSB
Regulation Number888.3020
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221084
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. Dyna Locking Trochanteric Nail™ (K221084) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182783 | DePuy Synthes Trauma Orthopedic Nail Implants | DePuy Synthes | 2018 |
| K093707 | DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820 | U&I Corp. | 2010 |
Trace the full predicate network for K221084
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.