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FDA 510(k)

REGENEROSS ALLOGRAFT PLUS MINERLIZED

K-Number: K113645 · 2012-01-20

ApplicantBiomet Interpore Cross
Decision Date2012-01-20
Product CodeNUN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REGENEROSS ALLOGRAFT PLUS MINERLIZED is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Interpore Cross. It received FDA 510(k) clearance on 2012-01-20 under 510(k) number K113645. 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 REGENEROSS ALLOGRAFT PLUS MINERLIZED?

REGENEROSS ALLOGRAFT PLUS MINERLIZED is a medical device that received FDA 510(k) clearance on 2012-01-20. The listed applicant is Biomet Interpore Cross. The 510(k) number is K113645.

When did REGENEROSS ALLOGRAFT PLUS MINERLIZED receive FDA 510(k) clearance?

REGENEROSS ALLOGRAFT PLUS MINERLIZED received FDA 510(k) clearance on 2012-01-20, under 510(k) number K113645.

Who is the listed applicant for REGENEROSS ALLOGRAFT PLUS MINERLIZED?

The FDA 510(k) record lists Biomet Interpore Cross as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REGENEROSS ALLOGRAFT PLUS MINERLIZED?

The FDA product code for REGENEROSS ALLOGRAFT PLUS MINERLIZED is NUN.

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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.

K103699EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCCExactech, Inc.K091217DBX DEMINERALIZED BONE MATRIX PUTTYMusculoskeletal Transplant FoundationK082463PROGENIXMedtronic Sofamor DanekK081950PROGENIX PLUSMedtronic Sofamor Danek, Inc.K080462PROGENIX DBM PUTTYMedtronic Sofamor DanekK080418REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PASTRegeneration Technologies, 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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