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FDA 510(k)

ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY

K-Number: K060306 · 2006-03-27

ApplicantIsotis NV
Decision Date2006-03-27
Product CodeNUN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACCELL CONNEXUS DEMINERALIZED BONE MATRIX 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 2006-03-27 under 510(k) number K060306. 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 ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY?

ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY is a medical device that received FDA 510(k) clearance on 2006-03-27. The listed applicant is Isotis NV. The 510(k) number is K060306.

When did ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY receive FDA 510(k) clearance?

ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY received FDA 510(k) clearance on 2006-03-27, under 510(k) number K060306.

Who is the listed applicant for ACCELL CONNEXUS DEMINERALIZED BONE MATRIX 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 ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY?

The FDA product code for ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY is NUN.

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Other records listing Isotis NV 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.

K061880ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCK060332ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND 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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