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FDA 510(k)

OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY

K-Number: K130498 · 2013-05-31

ApplicantBacterin International, Inc.
Decision Date2013-05-31
Product CodeMBP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY is the device name listed in this FDA 510(k) record. The listed applicant is Bacterin International, Inc.. It received FDA 510(k) clearance on 2013-05-31 under 510(k) number K130498. 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 OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY?

OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY is a medical device that received FDA 510(k) clearance on 2013-05-31. The listed applicant is Bacterin International, Inc.. The 510(k) number is K130498.

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

OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY received FDA 510(k) clearance on 2013-05-31, under 510(k) number K130498.

Who is the listed applicant for OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY?

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

What is the FDA product code for OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY?

The FDA product code for OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY is MBP.

Related Clinical Trials

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.

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Other records listing Bacterin International, 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.

K091321OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYK063245ELUTIA COATED CLOSED SURGICAL WOUND DRAIN

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.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 SciencesK091193ACCELL EVO3CIsotis Orthobiologics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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