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 LEIBINGER SKELETAL ANCHORING SYSTEM

K-Number: K041651 · 2004-09-30

ApplicantStryker Leibinger
Decision Date2004-09-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger. It received FDA 510(k) clearance on 2004-09-30 under 510(k) number K041651. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM?

STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-30. The listed applicant is Stryker Leibinger. The 510(k) number is K041651.

When did STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM receive FDA 510(k) clearance?

STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM received FDA 510(k) clearance on 2004-09-30, under 510(k) number K041651.

Who is the listed applicant for STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM?

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

What is the FDA product code for STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM?

The FDA product code for STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM is DZE.

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 Leibinger 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.

K052871STRYKER CUSTOM TI IMPLANTK043250STRYKER PATIENT SPECIFIC POLYMER IMPLANTK040022STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEMK022579STRYKER NAVIGATION SYSTEM-KNEE MODULEK023449NON-INVASIVE PATIENT FIXATION SYSTEMK013775TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM

View all 12 devices →

Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, 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.

↑