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)

ISS INTEGRATED SPINE SYSTEM

K-Number: K061524 · 2006-09-26

ApplicantOrtho Development Corp.
Decision Date2006-09-26
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ISS INTEGRATED SPINE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corp.. It received FDA 510(k) clearance on 2006-09-26 under 510(k) number K061524. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISS INTEGRATED SPINE SYSTEM?

ISS INTEGRATED SPINE SYSTEM is a medical device that received FDA 510(k) clearance on 2006-09-26. The listed applicant is Ortho Development Corp.. The 510(k) number is K061524.

When did ISS INTEGRATED SPINE SYSTEM receive FDA 510(k) clearance?

ISS INTEGRATED SPINE SYSTEM received FDA 510(k) clearance on 2006-09-26, under 510(k) number K061524.

Who is the listed applicant for ISS INTEGRATED SPINE SYSTEM?

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

What is the FDA product code for ISS INTEGRATED SPINE SYSTEM?

The FDA product code for ISS INTEGRATED SPINE SYSTEM is MNH. This falls under the ENT category.

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 Development Corp. 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.

K253161Balanced Knee System TriMax Porous Femoral ComponentsK251052Trivicta® Hip StemK242984BKS Revision SystemK242833Legend® Acetabular ShellK233758Trivicta™ Hip StemK131022OVATION 10/12 HIP STEM

View all 41 devices →

Related Devices (Code: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S 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.

↑