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FDA 510(k)

REPLAM HYDROXYAPATITE

K-Number: K830304 · 1983-04-06

ApplicantReplam Corp.
Decision Date1983-04-06
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REPLAM HYDROXYAPATITE is the device name listed in this FDA 510(k) record. The listed applicant is Replam Corp.. It received FDA 510(k) clearance on 1983-04-06 under 510(k) number K830304. 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 REPLAM HYDROXYAPATITE?

REPLAM HYDROXYAPATITE is a medical device that received FDA 510(k) clearance on 1983-04-06. The listed applicant is Replam Corp.. The 510(k) number is K830304.

When did REPLAM HYDROXYAPATITE receive FDA 510(k) clearance?

REPLAM HYDROXYAPATITE received FDA 510(k) clearance on 1983-04-06, under 510(k) number K830304.

Who is the listed applicant for REPLAM HYDROXYAPATITE?

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

What is the FDA product code for REPLAM HYDROXYAPATITE?

The FDA product code for REPLAM HYDROXYAPATITE is LYC.

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.

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Other records listing Replam Corp. 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.

K822420REPLAM HYDROXYAPATATITE

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

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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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