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FDA 510(k)

BONEGEN - TR

K-Number: K060285 · 2006-03-16

ApplicantBio-Lok Intl., Inc.
Decision Date2006-03-16
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONEGEN - TR is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Lok Intl., Inc.. It received FDA 510(k) clearance on 2006-03-16 under 510(k) number K060285. 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 BONEGEN - TR?

BONEGEN - TR is a medical device that received FDA 510(k) clearance on 2006-03-16. The listed applicant is Bio-Lok Intl., Inc.. The 510(k) number is K060285.

When did BONEGEN - TR receive FDA 510(k) clearance?

BONEGEN - TR received FDA 510(k) clearance on 2006-03-16, under 510(k) number K060285.

Who is the listed applicant for BONEGEN - TR?

The FDA 510(k) record lists Bio-Lok Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONEGEN - TR?

The FDA product code for BONEGEN - TR is LYC.

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Other records listing Bio-Lok Intl., Inc. 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.

K041136MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTSK032454SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM)

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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