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FDA 510(k)

SYNTHETIC GLASS BONE GRAFT MATERIAL

K-Number: K000633 · 2000-05-25

ApplicantBlue Sky Bio
Decision Date2000-05-25
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYNTHETIC GLASS BONE GRAFT MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Blue Sky Bio. It received FDA 510(k) clearance on 2000-05-25 under 510(k) number K000633. 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 SYNTHETIC GLASS BONE GRAFT MATERIAL?

SYNTHETIC GLASS BONE GRAFT MATERIAL is a medical device that received FDA 510(k) clearance on 2000-05-25. The listed applicant is Blue Sky Bio. The 510(k) number is K000633.

When did SYNTHETIC GLASS BONE GRAFT MATERIAL receive FDA 510(k) clearance?

SYNTHETIC GLASS BONE GRAFT MATERIAL received FDA 510(k) clearance on 2000-05-25, under 510(k) number K000633.

Who is the listed applicant for SYNTHETIC GLASS BONE GRAFT MATERIAL?

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

What is the FDA product code for SYNTHETIC GLASS BONE GRAFT MATERIAL?

The FDA product code for SYNTHETIC GLASS BONE GRAFT MATERIAL is LYC.

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Other records listing Blue Sky Bio 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.

K182338Blue Sky Bio Computerized Orthodontic Bracket SystemK163251Life Essence Universal Porcelain SystemK021833MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEMK010882BLUE SKY BIO DENTAL IMPLANT SYSTEM

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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