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)

WELLS JOHNSON FIXATION SYSTEM

K-Number: K945500 · 1995-09-21

ApplicantWells Johnson Co.
Decision Date1995-09-21
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WELLS JOHNSON FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wells Johnson Co.. It received FDA 510(k) clearance on 1995-09-21 under 510(k) number K945500. 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 WELLS JOHNSON FIXATION SYSTEM?

WELLS JOHNSON FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1995-09-21. The listed applicant is Wells Johnson Co.. The 510(k) number is K945500.

When did WELLS JOHNSON FIXATION SYSTEM receive FDA 510(k) clearance?

WELLS JOHNSON FIXATION SYSTEM received FDA 510(k) clearance on 1995-09-21, under 510(k) number K945500.

Who is the listed applicant for WELLS JOHNSON FIXATION SYSTEM?

The FDA 510(k) record lists Wells Johnson Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WELLS JOHNSON FIXATION SYSTEM?

The FDA product code for WELLS JOHNSON FIXATION SYSTEM 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 Wells Johnson Co. 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.

K991437WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00K984448BIRCOLL BALLOON DISSECTORK971580UAS ULTRASONIC ASPIRATOR SYSTEMK945876WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTK951519WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTK945877WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT

View all 15 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.

↑