Atlas FDA

Huvex Interspinous Fixation System

FDA 510(k) clearance K162849 · decided 2017-02-16

Clearance details

K-number
K162849
Device name
Huvex Interspinous Fixation System
Applicant
Dio Medical Co., Ltd.
Decision
Substantially Equivalent
Date received
2016-10-11
Decision date
2017-02-16
Days to decision
128 days
Clearance type
Traditional
Product code
PEK
Device class
2
Regulation number
888.3050
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Jungwon-Gu Sungnam-Si, KR
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.