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FDA 510(k)

ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY

K-Number: K060332 · 2006-03-29

ApplicantIsotis NV
Decision Date2006-03-29
Product CodeNUN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY is the device name listed in this FDA 510(k) record. The listed applicant is Isotis NV. It received FDA 510(k) clearance on 2006-03-29 under 510(k) number K060332. The device is classified under product code NUN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY?

ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY is a medical device that received FDA 510(k) clearance on 2006-03-29. The listed applicant is Isotis NV. The 510(k) number is K060332.

When did ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY receive FDA 510(k) clearance?

ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY received FDA 510(k) clearance on 2006-03-29, under 510(k) number K060332.

Who is the listed applicant for ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY?

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

What is the FDA product code for ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY?

The FDA product code for ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY is NUN.

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Other records listing Isotis NV as applicant

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K061880ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCK060306ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTYK031813OSSATURA DENTALK041344OPEN BORE SYRINGEK030131OSSATURA BCP BONE VOID FILLERK010840SYNPLUG

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Related Devices (Code: NUN)

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.

K113645REGENEROSS ALLOGRAFT PLUS MINERLIZEDBiomet Interpore CrossK103699EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCCExactech, Inc.K091217DBX DEMINERALIZED BONE MATRIX PUTTYMusculoskeletal Transplant FoundationK082463PROGENIXMedtronic Sofamor DanekK081950PROGENIX PLUSMedtronic Sofamor Danek, Inc.K080462PROGENIX DBM PUTTYMedtronic Sofamor Danek

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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