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)

AXIAL AND OFFSET CROSSLINK PLATES

K-Number: K896740 · 1990-02-26

ApplicantDanek Medical, Inc.
Decision Date1990-02-26
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AXIAL AND OFFSET CROSSLINK PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Danek Medical, Inc.. It received FDA 510(k) clearance on 1990-02-26 under 510(k) number K896740. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXIAL AND OFFSET CROSSLINK PLATES?

AXIAL AND OFFSET CROSSLINK PLATES is a medical device that received FDA 510(k) clearance on 1990-02-26. The listed applicant is Danek Medical, Inc.. The 510(k) number is K896740.

When did AXIAL AND OFFSET CROSSLINK PLATES receive FDA 510(k) clearance?

AXIAL AND OFFSET CROSSLINK PLATES received FDA 510(k) clearance on 1990-02-26, under 510(k) number K896740.

Who is the listed applicant for AXIAL AND OFFSET CROSSLINK PLATES?

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

What is the FDA product code for AXIAL AND OFFSET CROSSLINK PLATES?

The FDA product code for AXIAL AND OFFSET CROSSLINK PLATES is KWP.

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 Danek Medical, 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.

K994122BONE GRAFT WASHER, MODEL 9090114 - 9090118K993810CD HORIZON SPINAL SYSTEMK993855ATLANTIS ANTERIOR CERVICAL PLATE SYSTEMK991528MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTORK990603MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEMK982875MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM

View all 56 devices →

Related Devices (Code: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, 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.

↑