FDA.report

510(k) K201831

Device
CONFIDENCE Spinal Cement System
Applicant
Depuy Spine, Inc.
510(k) number
K201831
Product code
NDN
Decision
Substantially Equivalent (SESE)
Decision date
2020-08-31
Date received
2020-07-02
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
N

Related Records

Applicant Contact

Contact
Sergio M. Cordeiro
Address
325 Paramount Dr. Raynham MA US 02767 02767

FDA Registration Numbers

Source Documents

510(k) summary PDF

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