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FDA 510(k)

GRAFTON DBM

K-Number: K051195 · 2005-12-16

ApplicantOsteotech, Inc.
Decision Date2005-12-16
Product CodeMBP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GRAFTON DBM is the device name listed in this FDA 510(k) record. The listed applicant is Osteotech, Inc.. It received FDA 510(k) clearance on 2005-12-16 under 510(k) number K051195. The device is classified under product code MBP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAFTON DBM?

GRAFTON DBM is a medical device that received FDA 510(k) clearance on 2005-12-16. The listed applicant is Osteotech, Inc.. The 510(k) number is K051195.

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

GRAFTON DBM received FDA 510(k) clearance on 2005-12-16, under 510(k) number K051195.

Who is the listed applicant for GRAFTON DBM?

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 DBM?

The FDA product code for GRAFTON DBM is MBP.

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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: MBP)

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.

K242799PliaFX FloLifenet HealthK130703VIVORTE BVFVivorte, Inc.K130498OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBacterin International, Inc.K122513CLEARED UNDER GRAFTON II EDBMMedtronic Sofamor Danek, Inc.K113728SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTYHans Biomed Corp.K103742ACCELL EVO3 (FORMERLY ACCELL A2I)Integra Life Sciences

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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