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)

MODIFIED RONGEURS FOR SPINAL & ORTH. S.

K-Number: K821358 · 1982-05-28

ApplicantDowns Surgical , Ltd.
Decision Date1982-05-28
Product CodeEMH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFIED RONGEURS FOR SPINAL & ORTH. S. is the device name listed in this FDA 510(k) record. The listed applicant is Downs Surgical , Ltd.. It received FDA 510(k) clearance on 1982-05-28 under 510(k) number K821358. The device is classified under product code EMH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED RONGEURS FOR SPINAL & ORTH. S.?

MODIFIED RONGEURS FOR SPINAL & ORTH. S. is a medical device that received FDA 510(k) clearance on 1982-05-28. The listed applicant is Downs Surgical , Ltd.. The 510(k) number is K821358.

When did MODIFIED RONGEURS FOR SPINAL & ORTH. S. receive FDA 510(k) clearance?

MODIFIED RONGEURS FOR SPINAL & ORTH. S. received FDA 510(k) clearance on 1982-05-28, under 510(k) number K821358.

Who is the listed applicant for MODIFIED RONGEURS FOR SPINAL & ORTH. S.?

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

What is the FDA product code for MODIFIED RONGEURS FOR SPINAL & ORTH. S.?

The FDA product code for MODIFIED RONGEURS FOR SPINAL & ORTH. S. is EMH.

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 Downs Surgical , Ltd. 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.

K903750ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-EK903747ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-UK903749ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-UK903748ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-VK900609SHEPPERD STRAIGHT AND CURVED NEEDLESK900616SHEPPERD CUTTING FORCEPS

View all 60 devices →

Related Devices (Code: EMH)

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.

K890256BONE RONGEUR, DOUBLE-ACTIONKinetic Medical ProductsK890255BONE RONGEUR, SINGLE-ACTIONKinetic Medical ProductsK854887MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLATWalter Lorenz Surgical, Inc.K851710586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORCArtiberiaK834190JAKOBI SURG. INSTRUMENTS #8 15Imm Enterprises , Ltd.K834366SURGICAL INSTRUMENTS & ACCESSORIESC.B.S. Biotechnics, 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.

↑