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)

SPIRAL RADIUS 90-D RODDING SYSTEM

K-Number: K020134 · 2002-04-15

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date2002-04-15
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPIRAL RADIUS 90-D RODDING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 2002-04-15 under 510(k) number K020134. 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 SPIRAL RADIUS 90-D RODDING SYSTEM?

SPIRAL RADIUS 90-D RODDING SYSTEM is a medical device that received FDA 510(k) clearance on 2002-04-15. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K020134.

When did SPIRAL RADIUS 90-D RODDING SYSTEM receive FDA 510(k) clearance?

SPIRAL RADIUS 90-D RODDING SYSTEM received FDA 510(k) clearance on 2002-04-15, under 510(k) number K020134.

Who is the listed applicant for SPIRAL RADIUS 90-D RODDING SYSTEM?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIRAL RADIUS 90-D RODDING SYSTEM?

The FDA product code for SPIRAL RADIUS 90-D RODDING 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 United States Surgical, A Division of Tyco Healthc 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.

K071406AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIERK071920AUTOSUTURE ABSORBABLE TACK AND APPLICATORK061288AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIERK062850AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERSK062326AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVEK061095AUTO SUTUR ENDO GIA STAPLERS

View all 218 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.

↑