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)

HARRINGTON SPINE INSTRUMENTATION

K-Number: K781443 · 1978-09-27

ApplicantOrthopedic Equipment Co., Inc.
Decision Date1978-09-27
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HARRINGTON SPINE INSTRUMENTATION is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Equipment Co., Inc.. It received FDA 510(k) clearance on 1978-09-27 under 510(k) number K781443. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARRINGTON SPINE INSTRUMENTATION?

HARRINGTON SPINE INSTRUMENTATION is a medical device that received FDA 510(k) clearance on 1978-09-27. The listed applicant is Orthopedic Equipment Co., Inc.. The 510(k) number is K781443.

When did HARRINGTON SPINE INSTRUMENTATION receive FDA 510(k) clearance?

HARRINGTON SPINE INSTRUMENTATION received FDA 510(k) clearance on 1978-09-27, under 510(k) number K781443.

Who is the listed applicant for HARRINGTON SPINE INSTRUMENTATION?

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

What is the FDA product code for HARRINGTON SPINE INSTRUMENTATION?

The FDA product code for HARRINGTON SPINE INSTRUMENTATION is KWP.

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 Orthopedic Equipment Co., 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.

K834035UNIVERSAL SELF-ALIGNING ACETABULAR COMK841189OEC/REZAIAN SPINAL FIXATORK800530SCHLEIN TRI-SURFACE ANKLEK781445SPREADERK790247TOURNIQUET TEST GAGEK790209FILTER SYSTEM, ALTNER DISPOSABLE

View all 45 devices →

Related Devices (Code: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, 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.

↑