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)

ORATRONICS ENDOSSEOUS FRAME ASSEMBLY

K-Number: K791366 · 1979-10-09

ApplicantOratronics, Inc.
Decision Date1979-10-09
Product CodeNRQ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORATRONICS ENDOSSEOUS FRAME ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Oratronics, Inc.. It received FDA 510(k) clearance on 1979-10-09 under 510(k) number K791366. The device is classified under product code NRQ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORATRONICS ENDOSSEOUS FRAME ASSEMBLY?

ORATRONICS ENDOSSEOUS FRAME ASSEMBLY is a medical device that received FDA 510(k) clearance on 1979-10-09. The listed applicant is Oratronics, Inc.. The 510(k) number is K791366.

When did ORATRONICS ENDOSSEOUS FRAME ASSEMBLY receive FDA 510(k) clearance?

ORATRONICS ENDOSSEOUS FRAME ASSEMBLY received FDA 510(k) clearance on 1979-10-09, under 510(k) number K791366.

Who is the listed applicant for ORATRONICS ENDOSSEOUS FRAME ASSEMBLY?

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

What is the FDA product code for ORATRONICS ENDOSSEOUS FRAME ASSEMBLY?

The FDA product code for ORATRONICS ENDOSSEOUS FRAME ASSEMBLY is NRQ.

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

Related Devices (Code: NRQ)

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.

K211872PiezoImplant SystemRex Implants, Inc.K981954VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTSHealthline Implants, Inc.K822969GENERATION 5 LINKOW BLADE IMPLANTSLeonard P. Linkow, D.D.L.K791204MITER ENDOSTEAL BLADE IMPLANTDepuy, 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.

↑