Pure Global
240349
III
current

Orthopedic Internal Fixation Systems้ชจ็ง‘ๅ†…ๅ›บๅฎš็ณป็ปŸ

This profile provides complete Hong Kong MDACS registration information for Orthopedic Internal Fixation Systems. 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

็”ขๅ“่ณ‡่จŠ๏ผš ้ชจ็ง‘ๅ†…ๅ›บๅฎš็ณป็ปŸ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
16027
Product Code Detail
16027 Orthopedic Internal Fixation Systems
State
current
Status
N/A
Brand
CMF 1.5MM & 2.0MM System
CMF 1.5MMๅ’Œ2.0MM็ณป็ปŸ
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Biomet Microfixation
Biomet Microfixation, Llc
United States
็พŽๅ›ฝ
1520 Tradeport Drive, Jacksonville, Florida, 32218, USA
1520 Tradeport Drive, ๆฐๅ…‹้€Š็ปดๅฐ”, ไฝ›็ฝ—้‡Œ่พพๅทž, 32218, ็พŽๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
August 16, 2024
Expiry Date
August 15, 2029
Product Models
Cranial Facial plating (01-7040, 01-7045, 01-7047, 01-7048, 01-7050, 01-7055, 01-7057, 01-7062, 01-7065, 01-7066, 01-7068, 01-7069, 01-7092, 01-7093, 01-7100, 01-7102, 01-7104, 01-7110, 01-7112, 01-7114, 01-7120, 01-7131, 01-7136, 01-7137, 01-7180, 01-7182, 01-7185, 01-7250, 01-7251, 01-7340, 01-7345, 01-7347, 01-8013, 01-8014, 01-8018, 01-8019, 01-8604, 01-8636, 01-8637, 01-9180, 01-9216, 01-9250, 01-9251, 01-9260, 01-9262, 01-9272, 01-9280, 01-9281, 01-9291, 91-1803, 91-6103, 91-6104, 95-6103, 95-6104), Cranial Facial plating instruments (15-1194), Cranial Plating (01-7017, 01-7306, 01-7308, 01-7309, 01-7351, 01-7353, 01-7355, 01-7357, 01-7359, 01-7361, 01-7363, 01-9520, 01-9521, 01-9522, 01-9523, 01-9524, SP-1343, SP-1528, SP-1796, SP-1797, SP-1798, SP-1836, SP-1837, SP-1842, SP-1865, SP-2082, SP-2087, SP-2250, SP-2321), Facial plating (01-7106, 01-7107, 01-7108, 01-7109, 01-7126, 01-7128, 01-7130, 01-8610, 01-8611, 01-8612, 01-8613, 01-9226, 01-9228, 01-9229, 01-9274, 01-9278, 01-9282, 01-9284, 01-9285, 01-9286, 01-9287, 91-2019), Mandibular plating (91-5305, 91-5307, 91-5309, 91-5311), Twist drill (01-9192, 01-9193, 01-9195, 01-9196, 15-1725)
้ข…้ข้ƒจ้•€ๅฑ‚(01-7040ใ€01-7045ใ€01-7047ใ€01-7048ใ€01-7050ใ€01-7055ใ€01-7057ใ€01-7062ใ€01-7065ใ€01-7066ใ€01-7068ใ€01-7069ใ€01-7092ใ€01-7093ใ€01-7100ใ€01-7102ใ€01-7104ใ€01-7110ใ€01-7112ใ€01-7114ใ€01-7120ใ€01-7131ใ€01-7136ใ€01-7137ใ€01-7180ใ€01-7182ใ€01-7182ใ€01-7182ใ€01-7120 1-7185, 01-7250, 01-7251, 01-7340, 01-7345, 01-7347, 01-8013, 01-8014, 01-8018, 01-8019, 01-8604, 01-8636, 01-8637, 01-9180, 01-9216, 01-9250, 01-9251, 01-9260, 01-9262, 01-9272, 01-9280, 01-9281, 01-9291, 91-1803, 91-6103, 91-6104, 95-6103, 95-6104)ใ€้ข…้ข้•€ๅ™จๆขฐ(15-1194)ใ€้ข…้ข้•€ๅฑ‚(01-7017ใ€01-7306ใ€01-7308ใ€01-7309ใ€01-7351ใ€01-7353ใ€01-7355ใ€01-7357ใ€01-7359ใ€01-7361ใ€01-7363ใ€01-9520ใ€01-9521ใ€01-9522ใ€01-9523ใ€01-9524ใ€SP-1343ใ€SP-1528ใ€SP-1796ใ€SP-1797ใ€SP-1799 8ใ€SP-1836ใ€SP-1837ใ€SP-1842ใ€SP-1865ใ€SP-2082ใ€SP-2087ใ€SP-2250ใ€SP-2321)ใ€้ข้ƒจ็”ต้•€(01-7106ใ€01-7107ใ€01-7108ใ€01-7109ใ€01-7126ใ€01-7128ใ€01-7130ใ€01-8610ใ€01-8611ใ€01-8612ใ€01-8613ใ€01-9226ใ€01-9228ใ€01-9229ใ€01-9274ใ€01-9278ใ€ 01-9282, 01-9284, 01-9285, 01-9286, 01-9287, 91-2019)ใ€ไธ‹้ขŒๆฟ(91-5305ใ€91-5307ใ€91-5309ใ€91-5311)ใ€้บป่Šฑ้’ป(01-9192ใ€01-9193ใ€01-9195ใ€01-9196ใ€15-1725)