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FDA 510(k)

CYTOPLAST REGENTEX TITANIUM 250

K-Number: K972278 · 1997-08-06

ApplicantOsteogenics Co.
Decision Date1997-08-06
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CYTOPLAST REGENTEX TITANIUM 250 is the device name listed in this FDA 510(k) record. The listed applicant is Osteogenics Co.. It received FDA 510(k) clearance on 1997-08-06 under 510(k) number K972278. 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 CYTOPLAST REGENTEX TITANIUM 250?

CYTOPLAST REGENTEX TITANIUM 250 is a medical device that received FDA 510(k) clearance on 1997-08-06. The listed applicant is Osteogenics Co.. The 510(k) number is K972278.

When did CYTOPLAST REGENTEX TITANIUM 250 receive FDA 510(k) clearance?

CYTOPLAST REGENTEX TITANIUM 250 received FDA 510(k) clearance on 1997-08-06, under 510(k) number K972278.

Who is the listed applicant for CYTOPLAST REGENTEX TITANIUM 250?

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

What is the FDA product code for CYTOPLAST REGENTEX TITANIUM 250?

The FDA product code for CYTOPLAST REGENTEX TITANIUM 250 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 Osteogenics Co. 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.

K964342CYTOPLAST GBR

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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