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FDA 510(k)

REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST

K-Number: K080418 · 2008-04-30

ApplicantRegeneration Technologies, Inc.
Decision Date2008-04-30
Product CodeNUN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST is the device name listed in this FDA 510(k) record. The listed applicant is Regeneration Technologies, Inc.. It received FDA 510(k) clearance on 2008-04-30 under 510(k) number K080418. 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 REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST?

REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST is a medical device that received FDA 510(k) clearance on 2008-04-30. The listed applicant is Regeneration Technologies, Inc.. The 510(k) number is K080418.

When did REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST receive FDA 510(k) clearance?

REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST received FDA 510(k) clearance on 2008-04-30, under 510(k) number K080418.

Who is the listed applicant for REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST?

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

What is the FDA product code for REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST?

The FDA product code for REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST is NUN.

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Other records listing Regeneration Technologies, 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.

K072238BIOSET XCHK072327CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTONK063584STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937K060180BIOSET XCK060253STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.K052405STERLING INTERFERENC SCREW HT

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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.

K113645REGENEROSS ALLOGRAFT PLUS MINERLIZEDBiomet Interpore CrossK103699EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCCExactech, Inc.K091217DBX DEMINERALIZED BONE MATRIX PUTTYMusculoskeletal Transplant FoundationK082463PROGENIXMedtronic Sofamor DanekK081950PROGENIX PLUSMedtronic Sofamor Danek, Inc.K080462PROGENIX DBM PUTTYMedtronic Sofamor Danek

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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