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FDA 510(k)

SOCKET GRAFT

K-Number: K113049 · 2012-01-27

ApplicantSteiner Laboratories
Decision Date2012-01-27
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOCKET GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Steiner Laboratories. It received FDA 510(k) clearance on 2012-01-27 under 510(k) number K113049. 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 SOCKET GRAFT?

SOCKET GRAFT is a medical device that received FDA 510(k) clearance on 2012-01-27. The listed applicant is Steiner Laboratories. The 510(k) number is K113049.

When did SOCKET GRAFT receive FDA 510(k) clearance?

SOCKET GRAFT received FDA 510(k) clearance on 2012-01-27, under 510(k) number K113049.

Who is the listed applicant for SOCKET GRAFT?

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

What is the FDA product code for SOCKET GRAFT?

The FDA product code for SOCKET GRAFT 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 Steiner Laboratories 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.

K142130ORAL BONDK063010REGEN BIOCEMENTK052493SOCKET GRAFT

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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