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)

ELEVATOR

K-Number: K841356 · 1984-07-18

ApplicantTreace Medical, Inc.
Decision Date1984-07-18
Product CodeKAD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ELEVATOR is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical, Inc.. It received FDA 510(k) clearance on 1984-07-18 under 510(k) number K841356. The device is classified under product code KAD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELEVATOR?

ELEVATOR is a medical device that received FDA 510(k) clearance on 1984-07-18. The listed applicant is Treace Medical, Inc.. The 510(k) number is K841356.

When did ELEVATOR receive FDA 510(k) clearance?

ELEVATOR received FDA 510(k) clearance on 1984-07-18, under 510(k) number K841356.

Who is the listed applicant for ELEVATOR?

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

What is the FDA product code for ELEVATOR?

The FDA product code for ELEVATOR is KAD.

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 Treace Medical, 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.

K883727BUCKET PROSTHESIS PORPK882349MALLET, SURGICALK874779BIPOLATOR 50K873154TREACE MAGNUM OTO-TOOL SYSTEMK872000EYE GARDK870765CANNULATED INSTRUMENT CLEANERS

View all 80 devices →

Related Devices (Code: KAD)

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.

K822190ENT ELEVATORSKelleher Corp.K822270VARIOUS TYPES OF ENT ELEVATORSKelleher Corp.K772399DINGMAN ZYGOMA ELEVATOREdward Weck, Inc.K772391BOIES NASAL FRACTURE ELEVATOREdward Weck, 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.

↑