AFT ALLOGRAFT FILLER TUBE

Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

MUSCULOSKELETAL TRANSPLANT FOUNDATION

The following data is part of a premarket notification filed by Musculoskeletal Transplant Foundation with the FDA for Aft Allograft Filler Tube.

Pre-market Notification Details

Device IDK060161
510k NumberK060161
Device Name:AFT ALLOGRAFT FILLER TUBE
ClassificationFiller, Bone Void, Osteoinduction (w/o Human Growth Factor)
Applicant MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY STREET Edison,  NJ  08837
ContactNancy Bennewitz
CorrespondentNancy Bennewitz
MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY STREET Edison,  NJ  08837
Product CodeMBP  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-20
Decision Date2006-03-21
Summary:summary

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