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)

CHIN DISTRACTOR

K-Number: K973484 · 1997-12-02

ApplicantHowmedica, Inc.
Decision Date1997-12-02
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CHIN DISTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica, Inc.. It received FDA 510(k) clearance on 1997-12-02 under 510(k) number K973484. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHIN DISTRACTOR?

CHIN DISTRACTOR is a medical device that received FDA 510(k) clearance on 1997-12-02. The listed applicant is Howmedica, Inc.. The 510(k) number is K973484.

When did CHIN DISTRACTOR receive FDA 510(k) clearance?

CHIN DISTRACTOR received FDA 510(k) clearance on 1997-12-02, under 510(k) number K973484.

Who is the listed applicant for CHIN DISTRACTOR?

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

What is the FDA product code for CHIN DISTRACTOR?

The FDA product code for CHIN DISTRACTOR is JEY.

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 Howmedica, 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.

K984251XIA SPINE SYSTEMK984202HOWMEDICA HUMERAL INTERCALARY SYSTEMK984305ZETA MULTIZONE LOCKING NAIL SYSTEMK983885BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATESK983358G/K SFN AND STN LOCKING NAILSK982463EXTRACRANIAL RADIOTHERAPY SYSTEM

View all 36 devices →

Related Devices (Code: JEY)

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.

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsKLS-Martin L.P.K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.

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.

↑