Singapore HSA registration DE0018718
K2M NILE™ Alternative Fixation System
Singapore·CLASS C·K2M, Inc.·Registered November 08, 2016Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0018718
- Registration Date
- November 08, 2016
- Change Notification Approval Date
- April 14, 2017
- Retention Due Date
- November 07, 2025
Product description
The NILE Alternative Fixation Spinal System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: 1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis; 3. Spinal degenerative surgery, as an adjunct to spinal fusions. The NILE Alternative Fixation Spinal System may also be used in conjunction with other medical implants made of similar metals whenever ‘wiring’ may help secure the attachment of other implants.
Product Owner
- Name
- K2M, Inc.
- Short Name
- K2M, Inc.
- Address
- 600 Hope Parkway SE, Leesburg, Virginia, 20175, UNITED STATES
Registrant
- Address
- 1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
- Address
- 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model information
- Model Name(s)
- NILE™ Alternative Fixation System Clamp Assembly Size Ø4.5 mm NILE™ Alternative Fixation System Clamp Assembly Size Ø4.5 mm Rail / Ø6.0 mm NILE™ Alternative Fixation System Clamp Assembly Size Ø5.5 mm NILE™ Alternative Fixation System Clamp Assembly Size Ø5.5 mm Rail NILE™ Alternative Fixation System Band Size 3 mm NILE™ Alternative Fixation System Band Size 4 mm
- Model Identifier(s)
- 5401-84500 5401-84500H 5401-85500 5401-85500H 5416-F03730-SG 5416-F04730-SG
About this record
Access comprehensive regulatory information for K2M NILE™ Alternative Fixation System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0018718 and owned by K2M, Inc.. The device was registered on November 08, 2016.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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