FDA.report

510(k) K221307

Device
Edge Upper Cervical System
Applicant
Spinal Simplicity, LLC
510(k) number
K221307
Product code
NKG
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-10
Date received
2022-05-05
Regulation
888.3075
Classification name
Posterior Cervical Screw System
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
Adam Rogers
Address
6363 College Blvd. Suite 320 Overland Park KS US 66211 66211

FDA Registration Numbers

Source Documents

510(k) summary PDF

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