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)

MONOTUBE TUBE TO RING CLAMP

K-Number: K961618 · 1996-05-28

ApplicantHowmedica Corp.
Decision Date1996-05-28
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONOTUBE TUBE TO RING CLAMP is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1996-05-28 under 510(k) number K961618. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOTUBE TUBE TO RING CLAMP?

MONOTUBE TUBE TO RING CLAMP is a medical device that received FDA 510(k) clearance on 1996-05-28. The listed applicant is Howmedica Corp.. The 510(k) number is K961618.

When did MONOTUBE TUBE TO RING CLAMP receive FDA 510(k) clearance?

MONOTUBE TUBE TO RING CLAMP received FDA 510(k) clearance on 1996-05-28, under 510(k) number K961618.

Who is the listed applicant for MONOTUBE TUBE TO RING CLAMP?

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

What is the FDA product code for MONOTUBE TUBE TO RING CLAMP?

The FDA product code for MONOTUBE TUBE TO RING CLAMP is JEC.

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 Corp. 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.

K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

View all 373 devices →

Related Devices (Code: JEC)

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.

K203605SteriTrakArbutus Medical, Inc.K193256Anjon Bremer Halo SystemAnjon Holdings, LLCK192465DigiFix Sterile KitVirak Orthopedics, LLCK181192PIP FixHand Biomechanics Lab, Inc.K171863Anjon Bremer Halo SystemAnjon Holdings, LLCK163028Medline ReNewal Reprocessed Stryker External Fixation DevicesSurgical Instrument Service and Savings, 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.

↑