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)

MODIFICATION TO TENOR SPINAL SYSTEM

K-Number: K022191 · 2002-08-28

ApplicantMedtronic Sofamor Danek, Inc.
Decision Date2002-08-28
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO TENOR SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek, Inc.. It received FDA 510(k) clearance on 2002-08-28 under 510(k) number K022191. 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 MODIFICATION TO TENOR SPINAL SYSTEM?

MODIFICATION TO TENOR SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2002-08-28. The listed applicant is Medtronic Sofamor Danek, Inc.. The 510(k) number is K022191.

When did MODIFICATION TO TENOR SPINAL SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO TENOR SPINAL SYSTEM received FDA 510(k) clearance on 2002-08-28, under 510(k) number K022191.

Who is the listed applicant for MODIFICATION TO TENOR SPINAL SYSTEM?

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

What is the FDA product code for MODIFICATION TO TENOR SPINAL SYSTEM?

The FDA product code for MODIFICATION TO TENOR SPINAL SYSTEM 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 Medtronic Sofamor Danek, 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.

K251193Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone GraftK243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesK230716Robotic Graft Delivery InstrumentsK132897CLYDESDALE SPINAL SYSTEMK133216CRESCENT SPINAL SYSTEMK132700PERIMETER INTERBODY FUSION DEVICE

View all 96 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.

↑