Class Class II
Integrity™ Bone Staple Fixation System (K223860)
Description
Integrity™ Bone Staple Fixation System by Anika Therapeutics, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223860
Clearance Date2023-05-22
Clearance TypeTraditional
Product CodeMBI
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223860
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. Integrity™ Bone Staple Fixation System (K223860) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K131635 | ROTATION MEDICAL BONE STAPLE (RMB STAPLE) | Rotation Medical, Inc. | 2013 |
Trace the full predicate network for K223860
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.