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510(k) K221697

INJECTION PIN (KIP(02031-02061) (03031-03061)) by Slk Ortho, LLC — Product Code NDN

K221697 is an FDA 510(k) premarket notification submitted by Slk Ortho, LLC for the device "INJECTION PIN (KIP(02031-02061) (03031-03061))". The FDA issued a decision of Substantially Equivalent on March 3, 2023. 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
March 3, 2023
Date Received
June 10, 2022
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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FDA data resources