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GLOBUS MEDICAL SECURE-C Cervical Artificial Disc - HSA Registration DE0504133

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.

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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CLASS C
DE0504133
GLOBUS MEDICAL SECURE-C Cervical Artificial Disc
HSA Registration Number: DE0504133
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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.

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 Owner
Short Name
GLOBUS MEDICAL INC
Address
Valley Forge Business Center, 2560 General Armistead Avenue, Audubon, PA 19403, UNITED STATES
Registrant
Address
151 LORONG CHUAN, NEW TECH PARK, #04-03, SINGAPORE 556741
Importer
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, 0ยฐ SECURE-C Endplate Assembly, 11x12, 6ยฐ SECURE-C Endplate & Core Assembly, 11x12, 6mm, 6ยฐ SECURE-C Endplate & Core Assembly, 11x12, 6mm, 0ยฐ SECURE-C Endplate Assembly, 13x14, 0ยฐ SECURE-C Endplate Assembly, 13x14, 6ยฐ SECURE-C Endplate & Core Assembly, 13x14, 6mm, 6ยฐ SECURE-C Endplate & Core Assembly, 13x14, 6mm, 0ยฐ SECURE-C Endplate Assembly, 14x16, 0ยฐ SECURE-C Endplate Assembly, 14x16, 6ยฐ SECURE-C Endplate & Core Assembly, 14x16, 6mm, 6ยฐ SECURE-C Endplate & Core Assembly, 14x16, 6mm, 0ยฐ SECURE-C Endplate Assembly, 15x18, 0ยฐ SECURE-C Endplate Assembly, 15x18, 6ยฐ SECURE-C Endplate & Core Assembly, 15x18, 6mm, 6ยฐ SECURE-C Endplate & Core Assembly, 15x18, 6mm, 0ยฐ
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