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510(k) K181262

SpineJack Expansion Kit by Vexim SA — Product Code NDN

K181262 is an FDA 510(k) premarket notification submitted by Vexim SA for the device "SpineJack Expansion Kit". The FDA issued a decision of Substantially Equivalent on August 30, 2018. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2018
Date Received
May 11, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Bone, Vertebroplasty
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

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  • K223294 — SpineJack® Expansion Kit (December 20, 2022)
  • K220131 — KYPHON VuE Bone Cement (April 18, 2022)

FDA data resources