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)

MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM

K-Number: K123206 · 2013-02-07

ApplicantMaxim Surgical
Decision Date2013-02-07
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Maxim Surgical. It received FDA 510(k) clearance on 2013-02-07 under 510(k) number K123206. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM?

MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-02-07. The listed applicant is Maxim Surgical. The 510(k) number is K123206.

When did MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM receive FDA 510(k) clearance?

MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM received FDA 510(k) clearance on 2013-02-07, under 510(k) number K123206.

Who is the listed applicant for MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM?

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

What is the FDA product code for MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM?

The FDA product code for MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM is ODP.

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

Related Devices (Code: ODP)

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.

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED 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.

↑