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)

5.0MM SPINAL SCREWS

K-Number: K994288 · 2000-04-10

ApplicantOrtho Tec, LLC
Decision Date2000-04-10
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

5.0MM SPINAL SCREWS 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 2000-04-10 under 510(k) number K994288. 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 5.0MM SPINAL SCREWS?

5.0MM SPINAL SCREWS is a medical device that received FDA 510(k) clearance on 2000-04-10. The listed applicant is Ortho Tec, LLC. The 510(k) number is K994288.

When did 5.0MM SPINAL SCREWS receive FDA 510(k) clearance?

5.0MM SPINAL SCREWS received FDA 510(k) clearance on 2000-04-10, under 510(k) number K994288.

Who is the listed applicant for 5.0MM SPINAL SCREWS?

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 5.0MM SPINAL SCREWS?

The FDA product code for 5.0MM SPINAL SCREWS 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 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: 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.

↑