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510(k) Data Aggregation
K Number
K983006Device Name
OSTEO 5.0MM CANNULATED SCREW SYSTEM
Manufacturer
STRYKER OSTEONICS
Date Cleared
1998-11-23
(87 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
STRYKER OSTEONICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Osteo 5.0mm Cannulated Screw System is indicated for ligament fixation and long and small bone fracture fixation, which may include the following:
- Fixation of intermediate-sized fragments in fractures such as: .
- proximal and distal humerus fractures
- fractures of the olecranon process
- femoral fractures
- tibial plateau and metaphyseal fractures of the proximal and distal tibia
- medial and lateral malleolar and pilon fractures
- os calcis, talar, and patellar fractures -
- . Ligament fixation of the proximal humerus
- . Fractures of the pelvis and acetabulum
- . Arthrodesis of the tarsals
Device Description
The Osteo 5.0mm Cannulated Screw System consists of 5.0mm thread diameter self-tapping cannulated screws of varying lengths and one washer, the use of which is optional. The 5.0mm screw has a thread diameter of 5.0mm, a shaft diameter of 3.2mm, a head diameter of 6.0mm, and a cannulation diameter of 2.0mm. The washer for the 5.0 screws has an outer diameter of 8.0mm, an inner diameter of 4.5mm, and a thickness of 1.0mm. The surfaces of the screws and washers are anodized with a Type II coating. The screws and washers are provided both sterile and non-sterile.
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