510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PGNClass II

Growing Rod System- Magnetic Actuation

21 CFR 888.3070 / Orthopedic
FDA source (opens on fda.gov)

PGN is the FDA product code for Growing Rod System- Magnetic Actuation, a class II device type, regulated under 21 CFR 888.3070. FDA's definition for this code reads: "Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
PGN
Device name
Growing Rod System- Magnetic Actuation
FDA definition
Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod.
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
4

Clearances, product code PGN

By decision year
9 clearances under product code PGN with a decision year between 2014 and 2024, 2014 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PGN by decision year
YearClearances
20142
20152
20162
20171
20201
20241

Applicants with the most clearances

Product code PGN
Applicants holding the most 510(k) clearances under product code PGN
ApplicantClearances
Ellipse Technologies, Inc.3
NuVasive Specialized Orthopedics, Inc.3
Nuvasive Specialized Orthopedics, Incorporated2
Ellipse Technologies, Incorporated1

Companies listing this code with FDA

Companies whose registered establishments list this code