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)

SCS DT-02 TRANSVERSE CONNECTOR

K-Number: K003823 · 2001-07-11

ApplicantOrtho Tec, LLC
Decision Date2001-07-11
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCS DT-02 TRANSVERSE CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Tec, LLC. It received FDA 510(k) clearance on 2001-07-11 under 510(k) number K003823. 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 SCS DT-02 TRANSVERSE CONNECTOR?

SCS DT-02 TRANSVERSE CONNECTOR is a medical device that received FDA 510(k) clearance on 2001-07-11. The listed applicant is Ortho Tec, LLC. The 510(k) number is K003823.

When did SCS DT-02 TRANSVERSE CONNECTOR receive FDA 510(k) clearance?

SCS DT-02 TRANSVERSE CONNECTOR received FDA 510(k) clearance on 2001-07-11, under 510(k) number K003823.

Who is the listed applicant for SCS DT-02 TRANSVERSE CONNECTOR?

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

What is the FDA product code for SCS DT-02 TRANSVERSE CONNECTOR?

The FDA product code for SCS DT-02 TRANSVERSE CONNECTOR 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 Ortho Tec, LLC 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.

K040514EOVIA CALCIUM PHOSPHATE CERAMICK040346MODIFICATION TO ORIA TOP CLIP SYSTEMK030958ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORSK031471ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01K023884MODIFICATION ORIA SPINAL SYSTEMK023378ORIA CLARIS

View all 22 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.

↑