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FDA 510(k)

ORTHOVITA BIOGRAN

K-Number: K941780 · 1995-02-10

ApplicantOrthovita Co.
Decision Date1995-02-10
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHOVITA BIOGRAN is the device name listed in this FDA 510(k) record. The listed applicant is Orthovita Co.. It received FDA 510(k) clearance on 1995-02-10 under 510(k) number K941780. 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 ORTHOVITA BIOGRAN?

ORTHOVITA BIOGRAN is a medical device that received FDA 510(k) clearance on 1995-02-10. The listed applicant is Orthovita Co.. The 510(k) number is K941780.

When did ORTHOVITA BIOGRAN receive FDA 510(k) clearance?

ORTHOVITA BIOGRAN received FDA 510(k) clearance on 1995-02-10, under 510(k) number K941780.

Who is the listed applicant for ORTHOVITA BIOGRAN?

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

What is the FDA product code for ORTHOVITA BIOGRAN?

The FDA product code for ORTHOVITA BIOGRAN 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 Orthovita 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.

K994337VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLERK952922BIOGRAN BIOACTIVE GLASS SYNTHETIC BONE GRAFT MATERIAL

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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