Singapore HSA registration DE0508095
MEDICREA C-CURVE™ Stand-alone cervical cages
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0508095
- Registration Date
- May 16, 2023
- Change Notification Approval Date
- April 24, 2024
- Retention Due Date
- May 15, 2025
Product description
The stand-alone intersomatic C-CURVE™ implants are indicated for spinal fusion procedures in skeletally mature patients. C-CURVE™ stand-alone cages are designed to be used at the cervical level (between C3 and T1) as an internal anterior spine stabilizer. Properly used, these implants stabilize the spine until bone fusion occurs. Those implants are indicated for use with bone graft in patients with Degenerative Disc Disease (DDD indicated by disc herniation, cervical spondylosis and often accompanied by myelopathy, radiculopathy or myeloradiculopathy) at one or several levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. This implant must be used with bone graft. Patients should have failed to conservative treatment (usually at least six (6) week of non-operative treatment) prior to treatment with a C-CURVE™ stand-alone implant.
Product Owner
- Short Name
- MEDICREA INTERNATIONAL S.A.S
- Address
- 5389 Route de Strasbourg - Vancia, 69140 Rillieux-la-Pape, FRANCE
Registrant
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model information
- Model Name(s)
- DOUBLE METALLIC TRIAL C-CURVE 17x12 mm H:5-6 mm DOUBLE METALLIC TRIAL C-CURVE 17x12 mm H:7-8 mm DOUBLE METALLIC TRIAL C-CURVE 19x14 mm H:5-6 mm DOUBLE METALLIC TRIAL C-CURVE 19x14 mm H:7-8 mm C-Curve° lordosable Ti 17x12x5mm C-Curve° lordosable Ti 17x12x6mm C-Curve° lordosable Ti 17x12x7mm C-Curve° lordosable Ti 17x12x8mm C-Curve° lordosable Ti 19x14x5mm C-Curve° lordosable Ti 19x14x6mm C-Curve° lordosable Ti 19x14x7mm C-Curve° lordosable Ti 19x14x8mm C-Curve screws Ø3.5mm x L13mm X2 C-Curve screws Ø3.5mm x L15mm X2 C-Curve screws Ø3.5mm x L17mm X2
- Model Identifier(s)
- A20500156 A20500178 A20500256 A20500278 B20502153 B20502163 B20502173 B20502183 B20502253 B20502263 B20502273 B20502283 B20520013 B20520015 B20520017
About this record
Access comprehensive regulatory information for MEDICREA C-CURVE™ Stand-alone cervical cages in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508095 and owned by MEDICREA INTERNATIONAL S.A.S. The device was registered on May 16, 2023.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C