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FDA 510(k)

HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025

K-Number: K093390 · 2010-05-25

ApplicantDepuy Spine, Inc.
Decision Date2010-05-25
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Spine, Inc.. It received FDA 510(k) clearance on 2010-05-25 under 510(k) number K093390. 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 HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025?

HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 is a medical device that received FDA 510(k) clearance on 2010-05-25. The listed applicant is Depuy Spine, Inc.. The 510(k) number is K093390.

When did HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 receive FDA 510(k) clearance?

HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 received FDA 510(k) clearance on 2010-05-25, under 510(k) number K093390.

Who is the listed applicant for HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025?

The FDA 510(k) record lists Depuy Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025?

The FDA product code for HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 is LYC.

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Other records listing Depuy Spine, Inc. as applicant

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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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