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-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION

K-Number: K851367 · 1985-05-21

ApplicantOrthomatrix, Inc.
Decision Date1985-05-21
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Orthomatrix, Inc.. It received FDA 510(k) clearance on 1985-05-21 under 510(k) number K851367. 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 HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION?

HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION is a medical device that received FDA 510(k) clearance on 1985-05-21. The listed applicant is Orthomatrix, Inc.. The 510(k) number is K851367.

When did HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION receive FDA 510(k) clearance?

HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION received FDA 510(k) clearance on 1985-05-21, under 510(k) number K851367.

Who is the listed applicant for HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION?

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

What is the FDA product code for HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION?

The FDA product code for HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION 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 Orthomatrix, 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.

K010738CANNULATED PLUS SCREW SYSTEMK001254ORTHOMATRIX, INC. CERCLAGE SYSTEMK992850MAGELLAN TIBIAL INTRAMEDULLARY NAILK992856MAGELLAN HUMERAL INTRAMEDULLARY NAILK852766HA-1000 & HA-500 HYDROXYLAPATITE TOOTH ROOT SUBSTIK852765HA-2000 HYDROXYLAPATITE

View all 8 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.

↑