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)

CAPSURE PEDICLE SCREW SYSTEM

K-Number: K070245 · 2007-04-05

ApplicantSpine Wave, Inc.
Decision Date2007-04-05
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CAPSURE PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2007-04-05 under 510(k) number K070245. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPSURE PEDICLE SCREW SYSTEM?

CAPSURE PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2007-04-05. The listed applicant is Spine Wave, Inc.. The 510(k) number is K070245.

When did CAPSURE PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

CAPSURE PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2007-04-05, under 510(k) number K070245.

Who is the listed applicant for CAPSURE PEDICLE SCREW SYSTEM?

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

What is the FDA product code for CAPSURE PEDICLE SCREW SYSTEM?

The FDA product code for CAPSURE PEDICLE SCREW SYSTEM is MNI.

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 Spine Wave, 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.

K260286Dynamo™ Spinal Cement; Salvo® Spine SystemK261159Exceed® Biplanar Expandable Interbody SystemK243816Testa TP Pivoting Spacer SystemK251131Annex® 2 Adjacent Level SystemK243514Salvo® Robotic Navigation InstrumentsK240685Salvo® Spine System

View all 49 devices →

Related Devices (Code: MNI)

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.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.

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.

↑