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510(k) K253118

Device
Companion Spine DIAM™ Instrumentation
Applicant
Companion Spine France
510(k) number
K253118
Product code
QLR
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-16
Date received
2025-09-24
Regulation
888.4520
Classification name
Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Nazanine Cloix
Address
5 Allée Des Acacias Mérignac FR 33700 33700

FDA Registration Numbers#

Source Documents#

510(k) summary PDF