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)

PEEK PREVAIL CERVICAL INTERBODY DEVICE

K-Number: K073285 · 2008-05-15

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2008-05-15
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PEEK PREVAIL CERVICAL INTERBODY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2008-05-15 under 510(k) number K073285. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEEK PREVAIL CERVICAL INTERBODY DEVICE?

PEEK PREVAIL CERVICAL INTERBODY DEVICE is a medical device that received FDA 510(k) clearance on 2008-05-15. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K073285.

When did PEEK PREVAIL CERVICAL INTERBODY DEVICE receive FDA 510(k) clearance?

PEEK PREVAIL CERVICAL INTERBODY DEVICE received FDA 510(k) clearance on 2008-05-15, under 510(k) number K073285.

Who is the listed applicant for PEEK PREVAIL CERVICAL INTERBODY DEVICE?

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

What is the FDA product code for PEEK PREVAIL CERVICAL INTERBODY DEVICE?

The FDA product code for PEEK PREVAIL CERVICAL INTERBODY DEVICE is OVE.

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 USA, 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.

K253011Catalyft PL Expandable Interbody SystemK261020Symmetrix™ L Spinal SystemK253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemK260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemK254165Infinity™ OCT SystemK253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)

View all 139 devices →

Related Devices (Code: OVE)

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.

K263049SABER-C SystemElevation SpineK261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLCK261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, 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.

↑