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FDA 510(k)

OSTIM

K-Number: K030052 · 2004-12-06

ApplicantHeraeus Kulzer, Inc.
Decision Date2004-12-06
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTIM is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 2004-12-06 under 510(k) number K030052. 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 OSTIM?

OSTIM is a medical device that received FDA 510(k) clearance on 2004-12-06. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K030052.

When did OSTIM receive FDA 510(k) clearance?

OSTIM received FDA 510(k) clearance on 2004-12-06, under 510(k) number K030052.

Who is the listed applicant for OSTIM?

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

What is the FDA product code for OSTIM?

The FDA product code for OSTIM is LYC.

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Related PubMed Literature

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.

PMID: 37306642Regulatory Framework for Implantable Neurostimulation Devices: Comparison of Systems in the US and European Union.Neuromodulation : journal of the International Neuromodulation Society ()

Other records listing Heraeus Kulzer, 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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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Related Devices (Code: LYC)

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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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