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

Bone Grafting Material, Human Source

REGENERATION TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Regeneration Technologies, Inc. with the FDA for Regenafil, Regenaform, Alriva Dbm Paste, Sltiva Dm With Cortical Cancellous Ships, Bioset, Sioset Ic, Rti Allograft Past.

Pre-market Notification Details

Device IDK080418
510k NumberK080418
Device Name:REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST
ClassificationBone Grafting Material, Human Source
Applicant REGENERATION TECHNOLOGIES, INC. 11621 RESEARCH CIR. P.O. BOX 2650 Alachua,  FL  32616 -2650
ContactTravis Arola
CorrespondentTravis Arola
REGENERATION TECHNOLOGIES, INC. 11621 RESEARCH CIR. P.O. BOX 2650 Alachua,  FL  32616 -2650
Product CodeNUN  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2008-02-15
Decision Date2008-04-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00854095006801 K080418 000
00191083045085 K080418 000
00191083045115 K080418 000
00854095006740 K080418 000
00854095006757 K080418 000
00854095006764 K080418 000
00854095006771 K080418 000
00854095006788 K080418 000
00854095006795 K080418 000
00191083045078 K080418 000

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