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 INJECTABLE CEMENT

K-Number: K060763 · 2006-09-22

ApplicantStryker
Decision Date2006-09-22
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STRYKER INJECTABLE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2006-09-22 under 510(k) number K060763. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER INJECTABLE CEMENT?

STRYKER INJECTABLE CEMENT is a medical device that received FDA 510(k) clearance on 2006-09-22. The listed applicant is Stryker. The 510(k) number is K060763.

When did STRYKER INJECTABLE CEMENT receive FDA 510(k) clearance?

STRYKER INJECTABLE CEMENT received FDA 510(k) clearance on 2006-09-22, under 510(k) number K060763.

Who is the listed applicant for STRYKER INJECTABLE CEMENT?

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

What is the FDA product code for STRYKER INJECTABLE CEMENT?

The FDA product code for STRYKER INJECTABLE CEMENT is GXP.

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 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.

K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMK230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®K230754L12 LED Light Source with AIMK2306051788 4K Camera System with Advanced Imaging ModalityK2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)K2221301688 4K Camera System with Advanced Imaging Modality

View all 79 devices →

Related Devices (Code: GXP)

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.

K251959TnR Cranial ImplantT&R BIOFAB CO., Ltd.K261265Permatage XT Settable Bone PuttyOrthocon, Inc.K253732Permatage Flowable, Settable Bone PasteOrthocon, Inc.K253854MONTAGE XT Cranial CementOrthocon, Inc.K241027Permatage Settable Bone PuttyOrthocon, Inc.K232771Montage Flowable Settable, Resorbable Bone PasteOrthocon, 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.

↑