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)

STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT

K-Number: K072118 · 2007-12-07

ApplicantStryker Corp.
Decision Date2007-12-07
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 2007-12-07 under 510(k) number K072118. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT?

STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT is a medical device that received FDA 510(k) clearance on 2007-12-07. The listed applicant is Stryker Corp.. The 510(k) number is K072118.

When did STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT receive FDA 510(k) clearance?

STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT received FDA 510(k) clearance on 2007-12-07, under 510(k) number K072118.

Who is the listed applicant for STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT?

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

What is the FDA product code for STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT?

The FDA product code for STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT is NDN.

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 Stryker 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.

K230045HipCheckK191259Stryker CrossFlow Integrated Arthroscopy PumpK182359HipCheckK122113MEMORY METAL STAPLES, EASYCLIPK122053SHAPEMATCH CUTTING GUIDEK122284HOFFMANN 3

View all 119 devices →

Related Devices (Code: NDN)

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.

K251896XeliteMed SuperM-Fix Spinal Bone CementXelite Biomed , Ltd.K250637VCFix Spinal SystemAmber ImplantsK243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemXelite Biomed , Ltd.K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed , Ltd.K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd.K240084V-STRUT® Vertebral ImplantHyprevention

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.

↑