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FDA 510(k)

GRAFTON PLUS DBM PASTE

K-Number: K042707 · 2005-11-30

ApplicantOsteotech, Inc.
Decision Date2005-11-30
Product CodeNUN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GRAFTON PLUS DBM PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Osteotech, Inc.. It received FDA 510(k) clearance on 2005-11-30 under 510(k) number K042707. 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 GRAFTON PLUS DBM PASTE?

GRAFTON PLUS DBM PASTE is a medical device that received FDA 510(k) clearance on 2005-11-30. The listed applicant is Osteotech, Inc.. The 510(k) number is K042707.

When did GRAFTON PLUS DBM PASTE receive FDA 510(k) clearance?

GRAFTON PLUS DBM PASTE received FDA 510(k) clearance on 2005-11-30, under 510(k) number K042707.

Who is the listed applicant for GRAFTON PLUS DBM PASTE?

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

What is the FDA product code for GRAFTON PLUS DBM PASTE?

The FDA product code for GRAFTON PLUS DBM PASTE is NUN.

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Other records listing Osteotech, 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.

K082615GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICESK081227PLEXUR MK080511PLEXUR-PK073405PLEXUR MK061982PLEXUR PK051188GRAFTON DBM

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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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