Class Class II
3DMatrix DynaFlex (DynaFlex) (K243302)
Description
3DMatrix DynaFlex (DynaFlex) by Printbio, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243302
Clearance Date2025-05-21
Clearance TypeTraditional
Product CodeOXF
Regulation Number878.3300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243302
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. 3DMatrix DynaFlex (DynaFlex) (K243302) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232602 | 3DMatrix Surgical Mesh | Printbio, Inc. | 2024 |
| K163217 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2017 |
| K052155 | BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED | C.R. Bard, Inc. | 2005 |
| K033337 | ULTRAPRO MESH | ETHICON, Inc. | 2004 |
Trace the full predicate network for K243302
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.