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 ALIGN

K-Number: K801952 · 1980-09-16

ApplicantB.H. Richardson, D.C.
Decision Date1980-09-16
Product CodeKYI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINE ALIGN is the device name listed in this FDA 510(k) record. The listed applicant is B.H. Richardson, D.C.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801952. The device is classified under product code KYI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINE ALIGN?

SPINE ALIGN is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is B.H. Richardson, D.C.. The 510(k) number is K801952.

When did SPINE ALIGN receive FDA 510(k) clearance?

SPINE ALIGN received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801952.

Who is the listed applicant for SPINE ALIGN?

The FDA 510(k) record lists B.H. Richardson, D.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINE ALIGN?

The FDA product code for SPINE ALIGN is KYI.

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: KYI)

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.

K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLCK180744Stablyx CMC Arthroplasty Implant SystemSkeletal Dynamics, LLCK111068STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5Skeletal Dynamics, LLCK112278ASCENSION NUGRIP CMC IMPLANTAscension OrthopedicK092548EXTREMITY MEDICAL TRAPEZIUM PROSTHESISExtremity Medical, LLCK061956ARTELON STT SPACERArtimplant AB

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.

↑