FDA 510(k)

Integrity Bone Staple Fixation System

K-Number: K223860 · 2023-05-22

Decision Date2023-05-22

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Integrity Bone Staple Fixation System is a medical device manufactured by Anika Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-05-22 under approval number K223860. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Integrity Bone Staple Fixation System?

Integrity Bone Staple Fixation System is a medical device that received FDA 510(k) clearance on 2023-05-22. It is manufactured by Anika Therapeutics, Inc.. The 510(k) number is K223860.

When was Integrity Bone Staple Fixation System approved by the FDA?

Integrity Bone Staple Fixation System received FDA 510(k) clearance on 2023-05-22, under approval number K223860.

What company makes Integrity Bone Staple Fixation System?

Integrity Bone Staple Fixation System is manufactured by Anika Therapeutics, Inc..

What is the FDA product code for Integrity Bone Staple Fixation System?

The FDA product code for Integrity Bone Staple Fixation System is MBI.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT07607496 MacuTherm Performance Study in Patients With iAMD NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT03466151 RESOLUTE ONYX China RCT Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026)

Other Devices by Anika Therapeutics, Inc.

K173008SCS 17-01 K190956SCS 17-01 K212083Tactoset Injectable Bone Substitute K231968Tactoset® Injectable Bone Substitute K223538Integrity Implant K222487Anika Tissue Tack Fixation System

View all 12 devices →

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.