FDA.reportPublic FDA data

510(k) K221697

Device
INJECTION PIN (KIP(02031-02061) (03031-03061))
Applicant
Slk Ortho, LLC
510(k) number
K221697
Product code
NDN
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-03
Date received
2022-06-10
Regulation
888.3027
Classification name
Cement, Bone, Vertebroplasty
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Lawrence Kluge
Address
5883 Rfd Long Grove IL US 60047 60047

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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