FDA.report

510(k) K230608

Device
SPICCA Stand-Alone Cervical Fusion Cages
Applicant
Southern Medical (Pty) , Ltd.
510(k) number
K230608
Product code
OVE
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-14
Date received
2023-03-03
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Cervical
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
Dalene Styger
Address
55 Regency Dr. Rte. 21 Corporate Park Irene ZA 0178 0178

FDA Registration Numbers

Source Documents

510(k) summary PDF

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