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FDA 510(k)

OSTEOSCAF

K-Number: K101827 · 2011-04-20

ApplicantTexas Innovative Medical Devices (Dba) Skeletal
Decision Date2011-04-20
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOSCAF is the device name listed in this FDA 510(k) record. The listed applicant is Texas Innovative Medical Devices (Dba) Skeletal. It received FDA 510(k) clearance on 2011-04-20 under 510(k) number K101827. 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 OSTEOSCAF?

OSTEOSCAF is a medical device that received FDA 510(k) clearance on 2011-04-20. The listed applicant is Texas Innovative Medical Devices (Dba) Skeletal. The 510(k) number is K101827.

When did OSTEOSCAF receive FDA 510(k) clearance?

OSTEOSCAF received FDA 510(k) clearance on 2011-04-20, under 510(k) number K101827.

Who is the listed applicant for OSTEOSCAF?

The FDA 510(k) record lists Texas Innovative Medical Devices (Dba) Skeletal as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSTEOSCAF?

The FDA product code for OSTEOSCAF is LYC.

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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

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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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