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)

HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE

K-Number: K925607 · 1993-11-08

ApplicantZimmer, Inc.
Decision Date1993-11-08
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1993-11-08 under 510(k) number K925607. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE?

HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE is a medical device that received FDA 510(k) clearance on 1993-11-08. The listed applicant is Zimmer, Inc.. The 510(k) number is K925607.

When did HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE receive FDA 510(k) clearance?

HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE received FDA 510(k) clearance on 1993-11-08, under 510(k) number K925607.

Who is the listed applicant for HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE?

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

What is the FDA product code for HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE?

The FDA product code for HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE is MEH.

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 Zimmer, 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.

K262955OsseoFit Stemless Shoulder SystemK260831Z1 Hip SystemK261683Augment Off-Axis Instrument SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

View all 344 devices →

Related Devices (Code: MEH)

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.

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® HA Femoral StemsExactech, 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.

↑