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Applicant profile

K2M, Inc.

K2M (Va)
Hong Kong MDACSUnited States14 registered devicesAug 28, 2015 – Jan 04, 2022
VerifiedMDD (Medical Device Division) · MDACS registry
14
Total devices
2
Risk classes
2015
First registration
2022
Most recent
Applicant overview
Applicant (EN)
K2M, Inc.
Applicant (ZH)
K2M (Va)
Country
United States
美国
Address
600 Hope Parkway SE, Leesburg, Virginia, 20175, USA
600 Hope Parkway SE, 利斯堡, 弗吉尼亚州, 20175, 美国
Timeline
First registration
Aug 28, 2015
Most recent
Jan 04, 2022
Regulatory footprint
Search K2M, Inc. across other regulatory registries
ThailandEuropean UnionColombiaSouth KoreaCanadaEcuador
Risk class breakdown
II3
III11
Recent MDACS registrations
Latest 15 devices linked to this applicant
Prosthesis Implantation Instruments, Orthopedic
假体植入器械,骨科
Jan 04, 2022
Risk class
II
Authorised rep
Stryker China Limited美国史赛克(中国)有限公司
Surgical Retractor Kits, Spine
外科牵开器套件,脊柱
Jun 09, 2021
Risk class
II
Authorised rep
Stryker China Limited美国史赛克(中国)有限公司
Orthopedic Internal Fixation Systems, Spinal
骨科内固定系统,脊柱
May 31, 2021
Risk class
III
Authorised rep
Stryker China Limited美国史赛克(中国)有限公司
Orthopedic Internal Fixation Systems, Spinal
骨科内固定系统,脊柱
May 26, 2021
Risk class
III
Authorised rep
Stryker China Limited美国史赛克(中国)有限公司
Orthopedic Internal Fixation Systems, Spinal
骨科内固定系统,脊柱
Mar 21, 2021
Risk class
III
Authorised rep
Stryker China Limited美国史赛克(中国)有限公司
Orthopedic Internal Fixation Systems, Spinal
骨科内固定系统,脊柱
Mar 21, 2021
Risk class
III
Authorised rep
Stryker China Limited美国史赛克(中国)有限公司
Orthopedic Internal Fixation Systems, Spinal
骨科内固定系统,脊柱
Dec 09, 2020
Risk class
III
Authorised rep
Stryker China Limited美国史赛克(中国)有限公司
Orthopedic Internal Fixation Systems
骨科内固定系统
Dec 09, 2020
Risk class
III
Authorised rep
Stryker China Limited美国史赛克(中国)有限公司
Orthopedic Internal Fixation Systems, Spinal
骨科内固定系统,脊柱
Dec 09, 2020
Risk class
III
Authorised rep
Stryker China Limited美国史赛克(中国)有限公司
Orthopedic Internal Fixation Systems, Spinal
骨科内固定系统,脊柱
Oct 10, 2020
Risk class
III
Authorised rep
Stryker China Limited美国史赛克(中国)有限公司
Bone Wires
骨线
Jul 13, 2017
Risk class
III
Authorised rep
Asia Actual Limited
Prosthesis Implantation Instruments, Orthopedic
假体植入器械,骨科
Sep 24, 2015
Risk class
II
Authorised rep
Hong Kong and Macau Regulatory Service香港及澳门法规服务有限公司
Orthopedic Internal Fixation Systems, Spinal
骨科内固定系统,脊柱
Aug 28, 2015
Risk class
III
Authorised rep
Hong Kong and Macau Regulatory Service香港及澳门法规服务有限公司
Orthopedic Internal Fixation Systems, Spinal
骨科内固定系统,脊柱
Aug 28, 2015
Risk class
III
Authorised rep
Hong Kong and Macau Regulatory Service香港及澳门法规服务有限公司
About this profile

K2M, Inc. is associated with 14 medical devices registered under the Hong Kong Medical Device Administrative Control System (MDACS). Explore bilingual product names, risk classes, authorised representatives, and life-cycle milestones.