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-TAC BONE ANCHOR SYSTEM

K-Number: K964953 · 1997-02-13

ApplicantInfluence, Inc.
Decision Date1997-02-13
Product CodeHXJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IN-TAC BONE ANCHOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Influence, Inc.. It received FDA 510(k) clearance on 1997-02-13 under 510(k) number K964953. The device is classified under product code HXJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN-TAC BONE ANCHOR SYSTEM?

IN-TAC BONE ANCHOR SYSTEM is a medical device that received FDA 510(k) clearance on 1997-02-13. The listed applicant is Influence, Inc.. The 510(k) number is K964953.

When did IN-TAC BONE ANCHOR SYSTEM receive FDA 510(k) clearance?

IN-TAC BONE ANCHOR SYSTEM received FDA 510(k) clearance on 1997-02-13, under 510(k) number K964953.

Who is the listed applicant for IN-TAC BONE ANCHOR SYSTEM?

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-TAC BONE ANCHOR SYSTEM?

The FDA product code for IN-TAC BONE ANCHOR SYSTEM is HXJ.

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: HXJ)

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.

K962372UROTAC BONE ANCHOR INSERTERInfluence, Inc.K930205ELECTRIC WIRE DRIVER, MODEL 2640EMicro Surgical Instruments Corp.K834515FIXATION STAPLE KIT - DLIDE HAMMERStryker Corp.K830456STAPLE INSERTER-EXTRACTOR FOR ARTHROSInstrument Makar, Inc.K830255OSTEOTOMY BONE STAPLETechmedica, Inc.

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.

↑