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510(k) Data Aggregation
K Number
K241186Device Name
Synthetic Bone Graft Particulate
Manufacturer
Shenzhen Dazhou Medical Technology Co., Ltd.
Date Cleared
2025-02-21
(298 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Dazhou Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Synthetic Bone Graft Particulate is intended to be used to augment the alveolar bone in tooth extraction procedures. (i.e., use in extraction sockets only)
Device Description
Synthetic Bone Graft Particulate is a synthetic absorbable osteoconductive bone graft substitute manufactured from 45S5 bioactive glass. The device is in particulate form with a size range of 0.5 mm to 1 mm.
The device is intended for augmenting alveolar bone in tooth extraction procedures. At time of use, the device is mixed with sterile saline to form a wet sandy paste that is applied to the defect. Synthetic Bone Graft Particulate is progressively resorbed and replaced by new bone tissue during the healing process.
It is supplied sterile, packaged in a rubber stopper-sealed glass bottle within a sterile barrier package (Tyvek-sealed PETG box). The device packages are protected by carboard box.
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K Number
K241073Device Name
DZ-Tabone Intervertebral Body Fusion Device
Manufacturer
Shenzhen Dazhou Medical Technology Co., Ltd.
Date Cleared
2024-12-06
(231 days)
Product Code
MAX, ODP
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Dazhou Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DZ-Tabone Intervertebral Body Fusion Device can be divided into two types, CIF-PTA and LIF-PTA.
The CIF-PTA is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with/ without radicular symptoms at one level from C2-Tl. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The CIF-PTA is intended for use with supplemental fixation systems and with autogenous bone graft. The CIF-PTA is implanted via an anterior approach.
The LIF-PTA is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic pam with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment. The LIF-PTA is implanted using a posterior approach and is intended to be used in pairs with supplemental fixation.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios.
Device Description
DZ-Tabone Intervertebral Body Fusion Device is a single device manufactured wholly from tantalum metallic material. It has a convex structure on the upper and lower surfaces, and a block structure as a whole. The device has a trabecular porous structure with a central bone graft window, facilitating vertebral fusion through bone ingrowth and providing stable support between vertebrae to maintain intervertebral space height.
The device intends to be used for spinal fusion surgery for patients with degenerative disc diseases, vertebral slippage, and instability of vertebrae. The surgery involves fusing one or two adjacent vertebral segments, with the option to implant in the cervical spine (C2-T1) or lumbar spine (L2-S1) vertebral gaps. It aims to restore the lost height due to vertebral lesions and is used in conjunction with an internal fixation system.
The Device is sterilized by irradiation and provided in a sterile form. These implants are intended for single use only and must not be reused under any circumstances.
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