Atlas FDA

GRAFTON DBM

FDA 510(k) clearance K051195 · decided 2005-12-16

Clearance details

K-number
K051195
Device name
GRAFTON DBM
Applicant
Osteotech, Inc.
Decision
Substantially Equivalent
Date received
2005-05-10
Decision date
2005-12-16
Days to decision
220 days
Clearance type
Traditional
Product code
MBP
Device class
2
Regulation number
888.3045
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Eatontown, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix recall (Z-0161-2024)Medtronic Sofamor Danek USA Inc2023-10-25
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix recall (Z-0162-2024)Medtronic Sofamor Danek USA Inc2023-10-25
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix recall (Z-0163-2024)Medtronic Sofamor Danek USA Inc2023-10-25
Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix recall (Z-0164-2024)Medtronic Sofamor Danek USA Inc2023-10-25
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demi recall (Z-0165-2024)Medtronic Sofamor Danek USA Inc2023-10-25
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone recall (Z-0166-2024)Medtronic Sofamor Danek USA Inc2023-10-25
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43 recall (Z-0167-2024)Medtronic Sofamor Danek USA Inc2023-10-25
Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAF recall (Z-1323-2023)Medtronic Sofamor Danek USA Inc2023-04-04
Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFT recall (Z-1324-2023)Medtronic Sofamor Danek USA Inc2023-04-04
Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T4209 recall (Z-1325-2023)Medtronic Sofamor Danek USA Inc2023-04-04
Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DB recall (Z-1326-2023)Medtronic Sofamor Danek USA Inc2023-04-04
Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM recall (Z-1327-2023)Medtronic Sofamor Danek USA Inc2023-04-04
Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; recall (Z-1328-2023)Medtronic Sofamor Danek USA Inc2023-04-04
Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GE recall (Z-1333-2023)Medtronic Sofamor Danek USA Inc2023-04-04
Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, M recall (Z-0977-2014)Medtronic Sofamor Danek USA Inc2014-02-12
Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft product containing demi recall (Z-0083-2013)Osteotech Inc2012-10-18
Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product containing demine recall (Z-0084-2013)Osteotech Inc2012-10-18
Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product containing demin recall (Z-0085-2013)Osteotech Inc2012-10-18
Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft product containing dem recall (Z-0086-2013)Osteotech Inc2012-10-18
Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product containing dem recall (Z-0087-2013)Osteotech Inc2012-10-18
Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft product containing recall (Z-0088-2013)Osteotech Inc2012-10-18
Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograft product contain recall (Z-0089-2013)Osteotech Inc2012-10-18
Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bone allograft produ recall (Z-0090-2013)Osteotech Inc2012-10-18
Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft produ recall (Z-0091-2013)Osteotech Inc2012-10-18
Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft produ recall (Z-0092-2013)Osteotech Inc2012-10-18
Optimum Expanse R Grafton is a human bone allograft product containing demineralized human recall (Z-0093-2013)Osteotech Inc2012-10-18
Optimum Expanse S Multiple sizes Grafton is a human bone allograft product containing demi recall (Z-0094-2013)Osteotech Inc2012-10-18
Grafton DBM Flex; Unit Size 5x5 cm; 1ea Container: Foil Pouch with Tyvek pouch Fracture re recall (Z-0415-2012)Osteotech Inc2012-01-11
Grafton DBM A-Flex; Unit Size 60 mm diam; 1ea Container: Foil Pouch with Tyvek pouch Fract recall (Z-0416-2012)Osteotech Inc2012-01-11