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)

INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER

K-Number: K954338 · 1996-03-21

ApplicantInnovasive Devices, Inc.
Decision Date1996-03-21
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER is the device name listed in this FDA 510(k) record. The listed applicant is Innovasive Devices, Inc.. It received FDA 510(k) clearance on 1996-03-21 under 510(k) number K954338. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER?

INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER is a medical device that received FDA 510(k) clearance on 1996-03-21. The listed applicant is Innovasive Devices, Inc.. The 510(k) number is K954338.

When did INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER receive FDA 510(k) clearance?

INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER received FDA 510(k) clearance on 1996-03-21, under 510(k) number K954338.

Who is the listed applicant for INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER?

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

What is the FDA product code for INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER?

The FDA product code for INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER is MBI.

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 Innovasive Devices, 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.

K994269TITAN RC TACKK993975ABSOLUTE ABSORBABLE INTERFERENCE SCREWK992458RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454K992377RC TACKK990454BIO-INTERFERENCE SCREWK984490SUTURELESS ANCHOR

View all 34 devices →

Related Devices (Code: MBI)

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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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.

↑