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FDA 510(k)

ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY

K-Number: K070751 · 2007-10-15

ApplicantIsotis Orthobiologics, Inc.
Decision Date2007-10-15
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY is the device name listed in this FDA 510(k) record. The listed applicant is Isotis Orthobiologics, Inc.. It received FDA 510(k) clearance on 2007-10-15 under 510(k) number K070751. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY?

ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY is a medical device that received FDA 510(k) clearance on 2007-10-15. The listed applicant is Isotis Orthobiologics, Inc.. The 510(k) number is K070751.

When did ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY receive FDA 510(k) clearance?

ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY received FDA 510(k) clearance on 2007-10-15, under 510(k) number K070751.

Who is the listed applicant for ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY?

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

What is the FDA product code for ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY?

The FDA product code for ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY is MQV.

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Other records listing Isotis Orthobiologics, Inc. as applicant

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Related Devices (Code: MQV)

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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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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