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FDA 510(k)

CSM SUBMERGED-R IMPLANT SYSTEM

K-Number: K111120 · 2011-10-14

ApplicantCsm Implant
Decision Date2011-10-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CSM SUBMERGED-R IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Csm Implant. It received FDA 510(k) clearance on 2011-10-14 under 510(k) number K111120. 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 CSM SUBMERGED-R IMPLANT SYSTEM?

CSM SUBMERGED-R IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-14. The listed applicant is Csm Implant. The 510(k) number is K111120.

When did CSM SUBMERGED-R IMPLANT SYSTEM receive FDA 510(k) clearance?

CSM SUBMERGED-R IMPLANT SYSTEM received FDA 510(k) clearance on 2011-10-14, under 510(k) number K111120.

Who is the listed applicant for CSM SUBMERGED-R IMPLANT SYSTEM?

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

What is the FDA product code for CSM SUBMERGED-R IMPLANT SYSTEM?

The FDA product code for CSM SUBMERGED-R IMPLANT 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 Csm Implant 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.

K173141CSM Submerged3-L Implant SystemK120043CSM INTERNAL-R IMPLANT SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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