Pure Global
220173
IV
current

Orthopedic Internal Fixation Systems, Spinal้ชจ็ง‘ๅ†…ๅ›บๅฎš็ณป็ปŸ,่„ŠๆŸฑ

This profile provides complete Hong Kong MDACS registration information for Orthopedic Internal Fixation Systems, Spinal. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.

Product Info: Orthopedic Internal Fixation Systems, Spinal

็”ขๅ“่ณ‡่จŠ๏ผš ้ชจ็ง‘ๅ†…ๅ›บๅฎš็ณป็ปŸ,่„ŠๆŸฑ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
15766
Product Code Detail
15766 Orthopedic Internal Fixation Systems, Spinal
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Globus Medical, Inc.
Globus Medical Inc
United States
็พŽๅ›ฝ
Valley Forge Business Center, 2560 General Armistead Avenue, Audubon, PA, 19403, United States of America
Valley Forge ๅ•†ๅŠกไธญๅฟƒ, 2560 General Armistead Avenue, Audubon, PA, 19403, ็พŽๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
June 01, 2022
Expiry Date
June 01, 2027
Product Models
SI-LOK Sacroiliac Joint Fixation System (139.501S, 139.502S, 139.503S, 139.504S, 139.505S, 139.506S, 139.507S, 139.508S, 139.521S, 139.522S, 139.523S, 139.524S, 139.525S, 139.526S, 139.527S, 139.528S, 139.605S, 139.606S, 139.607S, 139.608S, 139.625S, 139.626S, 139.627S, 139.628S, 139.682S, 139.683S, 139.684S, 139.685S, 139.686S, 139.687S, 139.688S, 139.702S, 139.703S, 139.704S, 139.705S, 139.706S, 139.707S, 139.708S, 139.722S, 139.723S, 139.724S, 139.725S, 139.726S, 139.727S, 139.728S, 139.784S, 139.785S, 139.786S, 139.787S, 139.788S, 139.804S, 139.805S, 139.806S, 139.807S, 139.808S, 139.824S, 139.825S, 139.826S, 139.827S, 139.828S, 630.401, 630.407, 632.150, 634.611, 639.001, 639.002, 639.003, 639.005, 639.006, 639.007, 639.008, 639.011, 639.015, 639.017, 639.020, 639.021, 639.050, 639.060, 639.114, 639.201, 639.208, 639.209, 639.210, 639.211, 639.212, 639.215, 639.216, 639.217, 639.218, 639.219, 639.220, 639.315, 639.407, 639.413, 639.415, 639.500, 639.600, 639.650, 639.651, 639.801, 639.802, 639.804, 639.808, 639.809, 639.900, 639.903, 639.904, 647.205, 647.209, 647.313, 647.413, 647.513, 647.515, 939.001, 939.002)
SI-LOK ้ชถ้ซ‚ๅ…ณ่Š‚ๅ›บๅฎš็ณป็ปŸ (139.501S, 139.502S, 139.503S, 139.504S, 139.505S, 139.506S, 139.507S, 139.508S, 139.521S, 139.522S, 139.523S, 139.524S, 139.524S, 139.. 525S, 139.526S, 139.527S, 139.528S, 139.605S, 139.606S, 139.607S, 139.608S, 139.625S, 139.626S, 139.627S, 139.628S, 139.682S, 139.683S, 139.684S, 139.685S, 139.686S, 139.687S, 139.688S, 139.702S, 139.703S, 139.704S, 139.705S, 139.706S, 139.707S, 139.722S, 139.722S, 139.728S 139.785S, 139.786S, 139.787S, 139.788S, 139.804S, 139.805S, 139.806S, 139.807S, 139.808S, 139.824S, 139.825S, 139.826S, 139.827S, 139.828S, 630.401, 630.407, 632.150, 634.611, 639,001, 639,002, 639, 003, 639,005, 639,006, 639,007, 639,008, 639,011, 639,015, 639,017, 639,020, 639,021, 639,050, 639,060, 639,114, 639,201, 639,208, 639,209, 639,210, 639,211, 639,212, 639,215, 639,216, 639,217, 639,218, 639,219, 639,220, 639,315, 639,407, 639,413, 639,415, 639,500, 639,600, 639,600, 639.802, 639.804, 639.808, 639.809, 639.900, 639.903, 639.904, 647.205, 647.209, 647.313, 647.413, 647.513, 647.515, 939.001, 939.002)