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510(k) Data Aggregation
K Number
K212135Device Name
Dry DBM- A Putty
Manufacturer
SeaSpine Corporation
Date Cleared
2021-10-04
(88 days)
Product Code
MQV, MBP
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
SeaSpine Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dry DBM-A Putty is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone
Device Description
Dry DBM-A Putty is made with demineralized human bone mixed with poloxamer resorbable reverse phase medium. Demineralized human bone is in the form of demineralized bone matrix (DBM) and a dispersed form of DBM, referred to as Accell Bone Matrix (ABM). Cancellous bone chips may also be added. Dry DBM-A Putty is formulated into a freeze-dried putty form and is provided in a sterile, single use package. As a human-derived material, some variations in the product should be expected, such as appearance and handling. Dry DBM-A Putty is packaged in a standard syringe.
The device is hydrated at the point of use with saline, blood, or bone marrow aspirate (BMA) (hydration fluid). Utilizing a standard male luer syringe available to the clinician in the Operating Room (not provided with the finished device), it is recommended to hydrate at a 0.8:1 fluid volume (relative to the stated graft volume). The hydration fluid is dispensed from the male luer syringe into the device syringe until reconstitution of the dry putty is achieved.
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