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)

SPINE-TECH CERVICAL FIXATION SYSTEM

K-Number: K931653 · 1994-08-04

ApplicantSpinal Technologies
Decision Date1994-08-04
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINE-TECH CERVICAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Technologies. It received FDA 510(k) clearance on 1994-08-04 under 510(k) number K931653. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINE-TECH CERVICAL FIXATION SYSTEM?

SPINE-TECH CERVICAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1994-08-04. The listed applicant is Spinal Technologies. The 510(k) number is K931653.

When did SPINE-TECH CERVICAL FIXATION SYSTEM receive FDA 510(k) clearance?

SPINE-TECH CERVICAL FIXATION SYSTEM received FDA 510(k) clearance on 1994-08-04, under 510(k) number K931653.

Who is the listed applicant for SPINE-TECH CERVICAL FIXATION SYSTEM?

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

What is the FDA product code for SPINE-TECH CERVICAL FIXATION SYSTEM?

The FDA product code for SPINE-TECH CERVICAL FIXATION SYSTEM is KWQ.

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: KWQ)

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.

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

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.

↑