160202
Orthopedic Internal Fixation Systems, Spinal
骨科内固定系统,脊柱
K2M, Inc.·III·Hong Kong MDACS·Registered May 26, 2021
Device overview
- Risk class
- III
- Product code
- 15766
- State
- current
- Status
- N/A
- Product code detail
- 15766 Orthopedic Internal Fixation Systems, Spinal
Manufacturer (製造商)
- Name
- K2M, Inc.K2M (Va)
- Country
- United States美国
- Address
- 600 Hope Parkway SE, Leesburg, Virginia, 20175, USA600 Hope Parkway SE, 利斯堡, 弗吉尼亚州, 20175, 美国
Authorised representative (AR)
- Name
- Stryker China Limited美国史赛克(中国)有限公司
- Phone
- 39691200
Regulatory timeline
- Registration date
- May 26, 2021
- Expiry date
- June 21, 2026
Product models
NILE Alternative Fixation System (5401-84500, 5401-84500H, 5401-85500, 5401-85500H, 5401-90000, 5401-90001, 5401-90002, 5401-90003, 5401-90005, 5401-90006, 5416-F03730-SG, 5416-F04730-SG)
尼罗河替代固定系统 (5401-84500, 5401-84500H, 5401-85500, 5401-85500H, 5401-90000, 5401-90001, 5401-90002, 5401-90003, 5401-90005, 5401-90006, 5416-F03730-SG, 5416-F04730-SG)
About this record
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
產品資訊： 骨科内固定系统,脊柱