The GIRO Growth Modulation System— 510(k) K220190

Substantially Equivalent

Pega Medical, Inc.

FDA 510(k) clearance K220190 for The GIRO Growth Modulation System, Substantially Equivalent on 2022-10-24. Applicant: Pega Medical, Inc.. Device class: 2.

Clearance details

Applicant
Pega Medical, Inc.
Product code
Code OBT
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Laval, CA
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