ClearanceBrief
Panels › Orthopedic › Product code MBP · Class 2

Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

Regulation 888.3045

0510(k)s in 12 months (31 all time)
2recalls in 12 months (43 all time)
39recalls that name a 510(k)
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Top companies in MBP

DateFirm and productCodeLinked 510(k)
Oct 9, 2026Medtronic 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
MBPK051188
K051195
Oct 9, 2026Medtronic 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 f
Open, Classified
MBPK042707
K043048
Oct 25, 2023Medtronic Sofamor Danek USA Inc
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix
Open, Classified
MBPK051195
Oct 25, 2023Medtronic Sofamor Danek USA Inc
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
Open, Classified
MBPK043048
K051195
Oct 25, 2023Medtronic Sofamor Danek USA Inc
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
Open, Classified
MBPK051195
Oct 25, 2023Medtronic Sofamor Danek USA Inc
Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix
Open, Classified
MBPK051195
Oct 25, 2023Medtronic Sofamor Danek USA Inc
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
Open, Classified
MBPK051195
Oct 25, 2023Medtronic Sofamor Danek USA Inc
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Open, Classified
MBPK051195
Oct 25, 2023Medtronic Sofamor Danek USA Inc
Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
Open, Classified
MBPK051195
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209; d) DBM T600306 XPANSE L
Open, Classified
MBPNone listed
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5CC GRAFTON GEL, REF T41110; d) DBM T41110INT 0.5CC GRAFTON GEL, R
Open, Classified
MBPK051195
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T5
Open, Classified
MBPNone listed
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matri
Open, Classified
MBPNone listed
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DB
Open, Classified
MBPNone listed
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; d) DBM T45001 1CC PASTE GR
Open, Classified
MBPK043048
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T
Open, Classified
MBPK051195
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200; d)
Open, Classified
MBPK051195
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135; c) DBM S44145 5CC ORTHOBLEND SMALL DEFECT, REF S44145; d)
Open, Classified
MBPK051195
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT; d) DBM T42
Open, Classified
MBPK051195
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105; d) DBM T44105INT 5CC GRAFTON CRU
Open, Classified
MBPK051195
Apr 4, 2023Medtronic Sofamor Danek USA Inc
Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PU
Open, Classified
MBPK051195
Jul 7, 2021Vivorte, Inc.
Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
Terminated
MBPK130703
K143547
May 3, 2019XTANT MEDICAL INC
OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect
Terminated
MBPK130498
Nov 8, 2016Wright Medical Technology, Inc.
PRO-STIM 10cc INJECTABLE, Part Number 86SR0410
Terminated
MBPK083270
Jun 16, 2016Musculoskeletal Transplant Foundation, Inc.
Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in
Terminated
MBPK042125
K060161
Jun 25, 2014Integra LifeSciences Corp.
Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and ga
Terminated
MBPK091193
Feb 12, 2014Medtronic 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
MBPK051188
K051195
Apr 17, 2013Bacterin International, Inc.
OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
Terminated
MBPK091321
Feb 11, 2013Bacterin International, Inc.
Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B0900
Terminated
MBPK091321
Oct 18, 2012Osteotech 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
MBPK042707
K043048 +2
Oct 18, 2012Osteotech 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
MBPK042707
K043048 +2
Oct 18, 2012Osteotech 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
MBPK042707
K043048 +2
Oct 18, 2012Osteotech 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
MBPK042707
K043048 +2
Oct 18, 2012Osteotech 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
MBPK042707
K043048 +2
Oct 18, 2012Osteotech 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
MBPK042707
K043048 +2
Oct 18, 2012Osteotech 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
MBPK042707
K043048 +2
Oct 18, 2012Osteotech 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
MBPK042707
K043048 +2
Oct 18, 2012Osteotech 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
MBPK042707
K043048 +2
Oct 18, 2012Osteotech 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
MBPK042707
K043048 +2
Oct 18, 2012Osteotech 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
MBPK042707
K043048 +2
Oct 18, 2012Osteotech 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
MBPK042707
K043048 +2
Jan 11, 2012Osteotech Inc
Grafton DBM A-Flex; Unit Size 60 mm diam; 1ea Container: Foil Pouch with Tyvek pouch Fracture repair, bridge bone gaps or fragments, use with strut grafts
Terminated
MBPK051195
Jan 11, 2012Osteotech Inc
Grafton DBM Flex; Unit Size 5x5 cm; 1ea Container: Foil Pouch with Tyvek pouch Fracture repair, bridge bone gaps or fragments, use with strut grafts
Terminated
MBPK051195

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