Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR

K-Number: K012465 · 2001-10-29

ApplicantBonutti Research, Inc.
Decision Date2001-10-29
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Bonutti Research, Inc.. It received FDA 510(k) clearance on 2001-10-29 under 510(k) number K012465. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR?

MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR is a medical device that received FDA 510(k) clearance on 2001-10-29. The listed applicant is Bonutti Research, Inc.. The 510(k) number is K012465.

When did MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR receive FDA 510(k) clearance?

MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR received FDA 510(k) clearance on 2001-10-29, under 510(k) number K012465.

Who is the listed applicant for MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR?

The FDA 510(k) record lists Bonutti Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR?

The FDA product code for MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR is MAI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bonutti Research, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K161628JAS Pulse(TM) Ultrasonic TherapyK093078UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORSK090175UNITY BETA PLLA SYSTEMK082906UNITY BETA ANCHOR SYSTEMK062820UNITY ALPHA SYSTEMK060283TRANSET SYSTEM

View all 12 devices →

Related Devices (Code: MAI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbHK254055OSSIOfiber® Suture AnchorOSSIO , Ltd.K251680Biosteon® ScrewBiocomposites, Ltd.K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation

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.

↑