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FDA 510(k)

HA-2000 HYDROXYLAPATITE

K-Number: K852765 · 1985-09-23

ApplicantOrthomatrix, Inc.
Decision Date1985-09-23
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HA-2000 HYDROXYLAPATITE is the device name listed in this FDA 510(k) record. The listed applicant is Orthomatrix, Inc.. It received FDA 510(k) clearance on 1985-09-23 under 510(k) number K852765. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HA-2000 HYDROXYLAPATITE?

HA-2000 HYDROXYLAPATITE is a medical device that received FDA 510(k) clearance on 1985-09-23. The listed applicant is Orthomatrix, Inc.. The 510(k) number is K852765.

When did HA-2000 HYDROXYLAPATITE receive FDA 510(k) clearance?

HA-2000 HYDROXYLAPATITE received FDA 510(k) clearance on 1985-09-23, under 510(k) number K852765.

Who is the listed applicant for HA-2000 HYDROXYLAPATITE?

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-2000 HYDROXYLAPATITE?

The FDA product code for HA-2000 HYDROXYLAPATITE is LYC.

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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 SUBSTIK851367HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION

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Related Devices (Code: LYC)

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.

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K244006FG Bone Graft MFull Golden Biotech Co., Ltd.K243745FG Bone Graft BFull Golden Biotech CorporationK241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.

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.

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