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)

IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW

K-Number: K970292 · 1997-04-23

ApplicantInfluence, Inc.
Decision Date1997-04-23
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Influence, Inc.. It received FDA 510(k) clearance on 1997-04-23 under 510(k) number K970292. 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 IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW?

IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW is a medical device that received FDA 510(k) clearance on 1997-04-23. The listed applicant is Influence, Inc.. The 510(k) number is K970292.

When did IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW receive FDA 510(k) clearance?

IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW received FDA 510(k) clearance on 1997-04-23, under 510(k) number K970292.

Who is the listed applicant for IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW?

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

What is the FDA product code for IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW?

The FDA product code for IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW 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 Influence, 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.

K981677REPOSE BONE SCREW SYSTEMK991792CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBEK992277STAPLETAC BONE ANCHOR SYSTEMK991122CRYO-MONO CRYOGRNIC SYSTEMK990160MICROTAC-BONE ANCHOR SYSTEMK990095STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM

View all 16 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.

↑