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FDA 510(k)

DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY

K-Number: K061131 · 2007-02-08

ApplicantOrthocon, Inc.
Decision Date2007-02-08
Product CodeMBP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY is the device name listed in this FDA 510(k) record. The listed applicant is Orthocon, Inc.. It received FDA 510(k) clearance on 2007-02-08 under 510(k) number K061131. 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 DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY?

DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY is a medical device that received FDA 510(k) clearance on 2007-02-08. The listed applicant is Orthocon, Inc.. The 510(k) number is K061131.

When did DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY receive FDA 510(k) clearance?

DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY received FDA 510(k) clearance on 2007-02-08, under 510(k) number K061131.

Who is the listed applicant for DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY?

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

What is the FDA product code for DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY?

The FDA product code for DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY is MBP.

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Other records listing Orthocon, Inc. as applicant

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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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