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510(k) Data Aggregation
K Number
K140229Device Name
GENERAL SPINAL SYSTEM
Manufacturer
TIANJIN WALKMAN BIOMATERIAL CO., LTD.
Date Cleared
2014-04-29
(89 days)
Product Code
MNI, MNH
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
TIANJIN WALKMAN BIOMATERIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The General Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion, (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8.
Device Description
The General Spinal System consists of Fixed-Angle Screws, Fix-Angle Reduction Screws, Hooks, Rods, Cross Link and Set Screws. It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications. which are widely used for surgical implants with well known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
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K Number
K132078Device Name
METALLIC INTRAMEDULLARY NAIL SYSTEM
Manufacturer
TIANJIN WALKMAN BIOMATERIAL CO., LTD.
Date Cleared
2014-03-19
(257 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
TIANJIN WALKMAN BIOMATERIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Simple, compound first- and second-degree tibial shaft fractures; Pseudarthrosis and delayed union.
Device Description
The Metallic Intramedullary Nail System, is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. The system consists of intramedullary nail, locking screw, end cap and instruments. The intramedullary nail is available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail.
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K Number
K131759Device Name
METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM
Manufacturer
TIANJIN WALKMAN BIOMATERIAL CO., LTD.
Date Cleared
2013-08-08
(52 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
TIANJIN WALKMAN BIOMATERIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Metallic Locking Compression Bone Plates and Screws System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
Device Description
Metallic Locking Compression Bone Plates and Screws System contains (1) locking compression plates (LCPs) with various specifications, (2) two kinds of screws with various specifications and (3) various specific instruments. Locking Compression Plates that made of Titanium. They have combi-holes. the threaded hole sections on the plates for locking screws provides ability to create fixed-angle constructs; the un-threaded hole sections for cortex screws allows utilization of familiar AO plating techniques. The limited-contact design of LCPs reduces plate-to-bone contact, thus limiting vascular trauma.The screws are available in locking screws and cortex screws. There are various instruments specific to the proposed device intend for completing the surgery.
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