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510(k) K051188 · NUN Bone Grafting Material, Human Source

GRAFTON DBM

Applicant	Osteotech, Inc., Eatontown NJ, US
Decision	Substantially Equivalent, Jan 3, 2006
Received	May 10, 2005
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K051188

Date	Firm and product	Code	Linked 510(k)
Oct 9, 2026	Medtronic Sofamor Danek USA Inc Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical for Open, Classified	MBP	None listed
Feb 12, 2014	Medtronic Sofamor Danek USA Inc Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - filler, bone void Terminated	MBP	None listed
Oct 18, 2012	Osteotech Inc Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft Terminated	MBP	None listed
Oct 18, 2012	Osteotech Inc Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. Terminated	MBP	None listed
Oct 18, 2012	Osteotech Inc Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. Terminated	MBP	None listed
Oct 18, 2012	Osteotech Inc Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograf Terminated	MBP	None listed
Oct 18, 2012	Osteotech Inc Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograf Terminated	MBP	None listed
Oct 18, 2012	Osteotech Inc Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allo Terminated	MBP	None listed
Oct 18, 2012	Osteotech Inc Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) a Terminated	MBP	None listed
Oct 18, 2012	Osteotech Inc Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matr Terminated	MBP	None listed
Oct 18, 2012	Osteotech Inc Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone mat Terminated	MBP	None listed
Oct 18, 2012	Osteotech Inc Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone mat Terminated	MBP	None listed
Oct 18, 2012	Osteotech Inc Optimum Expanse R Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intende Terminated	MBP	None listed
Oct 18, 2012	Osteotech Inc Optimum Expanse S Multiple sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft Terminated	MBP	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.