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510(k) Data Aggregation
K Number
K170056Device Name
IRENE Cannulated Screw System
Manufacturer
Date Cleared
2017-10-23
(290 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IRENE Cannulated Screw System is intended for fracture fixation, fusion and osteotomies of bones appropriate for the size of the device. For specific screw indications please see below.
Acutec Headless Compression Screw:
Used for fusion, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, calcaneus and other small bones.
Cannulated Screw:
Intended for bone fracture fixation and bone fragment fixation. Washers may be used with the Cannulated Screw in cases where the patient has poor bone quality.
Device Description
IRENE Cannulated Screw System includes two kinds of screws, Acutec Headless Compression Screw and Cannulated Screw. Acutec Headless Compression Screw has six different diameters in various lengths and is manufactured from Titanium Alloy (ASTM F 136 and ISO 5832-3). Cannulated Screw has four different diameters in various lengths and contains two optional washers. Cannulated Screw and washers are manufactured from Titanium Alloy (ISO 5832-3).
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K Number
K151508Device Name
IRENE Locking Compression Plate System
Manufacturer
Date Cleared
2016-02-25
(266 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IRENE Locking Compression Plate System is indicated for patients with age above 21 for fixation of fractures. Indicated facture areas include ulna, radius, humerus, femur, and tibia.
Device Description
The IRENE Locking Compression Plate System is designed for internal fixation of bones that subject to fracture. The system includes bone plates and screws that can be used with the plate. Various sizes of plate are available for different fracture areas or clinical conditions. Bone screws are incorporated in the system and are intended to fix with plate with appropriate size. The plate has a limited-contact design. The plate system is provided unsterile. And the system is intended for single-use.
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