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510(k) Data Aggregation
K Number
K190842Device Name
Comus Locking Plate systems
Manufacturer
Date Cleared
2020-02-03
(308 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Trauhui Medical Instrument Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Comus Locking Plate systems can be used for adult patients with age above 21 as indicated for fixation of Bone fracture in ulna, radius, humerus, femur and tibia.
Device Description
The proposed device Comus Locking Plate systems are a combination of plates and screws, which can be used for adult patients with age above 21 as indicated for fixation of fractures. The plate is made of Titanium, which meet ASTM F67, and the screw is made of titanium allov (Ti-6A-14V ELI) which conforms to ASTM F136, which both are widely used for surgical implants with well-known biocompatibility and mechanical properties.
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K Number
K172826Device Name
Cellent Spinal Systems
Manufacturer
Date Cleared
2018-10-10
(387 days)
Product Code
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Trauhui Medical Instrument Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Cellent Spinal Systems are intended for posterior pedicle screw fixation of the non-cervical posterior spine in sketally mature patients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or 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.
Cellent Spinal Systems are not intended for pedicle screw fixation above T8.
Device Description
Cellent Spinal System is a combination of pedicle screws, pedicle hooks, rods, set screws, connectors, and cross links, which can fix the vertebral body through pedicle or lamina. It is made of Titanium Alloy (Ti-6AL-41V ELI), which meet ASTM F136-13, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants.
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