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Singapore HSA registration DE0504133

GLOBUS MEDICAL SECURE-C Cervical Artificial Disc

Singapore flagSingapore·CLASS C·GLOBUS MEDICAL INC·Registered February 20, 2020
Device classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0504133
Registration Date
February 20, 2020
Change Notification Approval Date
February 13, 2025
Retention Due Date
February 19, 2026
Product description
The SECURE-C Cervical Artificial Discs are indicated for treatment of symptomatic cervical disc disease (SCDD) from C3-C7. SCDD is defined as neck or arm pain, or functional or neurological deficit confirmed by patient history and radiographic studies demonstrating primary or recurrent disc herniation, radiculopathy or myelopathy, spondylosis, spinal stenosis, and/or loss of disc height.
Product Owner
Name
GLOBUS MEDICAL INC
Short Name
GLOBUS MEDICAL INC
Address
Valley Forge Business Center, 2560 General Armistead Avenue, Audubon, PA 19403, UNITED STATES
Registrant
Name
NUVASIVE SOUTHEAST ASIA PTE. LTD.
Address
151 LORONG CHUAN, NEW TECH PARK, #04-03, SINGAPORE 556741
Importer
Name
NUVASIVE SOUTHEAST ASIA PTE. LTD. OPTO SYSTEMS (S) PTE. LTD.
Address
151 LORONG CHUAN, NEW TECH PARK, #04-03, SINGAPORE 556741 30 KALLANG PLACE, #06-06, SINGAPORE 339159
Model information
Model Name(s)
SECURE-C Core, 11x12, 7mm SECURE-C Core, 11x12, 8mm SECURE-C Core, 11x12, 9mm SECURE-C Core, 11x12, 10mm SECURE-C Core, 13x14, 7mm SECURE-C Core, 13x14, 8mm SECURE-C Core, 13x14, 9mm SECURE-C Core, 13x14, 10mm SECURE-C Core, 14x16, 7mm SECURE -C Core 14x16, 8mm SECURE-C Core, 14x16, 9mm SECURE-C Core, 14x16, 10mm SECURE-C Endplate Assembly, 11x12, 0° SECURE-C Endplate Assembly, 11x12, 6° SECURE-C Endplate & Core Assembly, 11x12, 6mm, 6° SECURE-C Endplate & Core Assembly, 11x12, 6mm, 0° SECURE-C Endplate Assembly, 13x14, 0° SECURE-C Endplate Assembly, 13x14, 6° SECURE-C Endplate & Core Assembly, 13x14, 6mm, 6° SECURE-C Endplate & Core Assembly, 13x14, 6mm, 0° SECURE-C Endplate Assembly, 14x16, 0° SECURE-C Endplate Assembly, 14x16, 6° SECURE-C Endplate & Core Assembly, 14x16, 6mm, 6° SECURE-C Endplate & Core Assembly, 14x16, 6mm, 0° SECURE-C Endplate Assembly, 15x18, 0° SECURE-C Endplate Assembly, 15x18, 6° SECURE-C Endplate & Core Assembly, 15x18, 6mm, 6° SECURE-C Endplate & Core Assembly, 15x18, 6mm, 0°
Model Identifier(s)
414.107S 414.108S 414.109S 414.110S 414.207S 414.208S 414.209S 414.210S 414.307S 414.308S 414.309S 414.310S 714.100S 714.106S 714.166S 714.176S 714.200S 714.206S 714.266S 714.276S 714.300S 714.306S 714.366S 714.376S 714.400S 714.406S 714.466S 714.476S
About this record

Access comprehensive regulatory information for GLOBUS MEDICAL SECURE-C Cervical Artificial Disc in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504133 and owned by GLOBUS MEDICAL INC. The device was registered on February 20, 2020.

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