510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161028Substantially Equivalent

K2M Growing Spine System

K2M, Inc, Leesburg VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161028 is the FDA 510(k) clearance record for K2M Growing Spine System, a class II device, cleared for K2m, Inc. on under FDA product code PGM (Growing Rod System). FDA's definition for product code PGM reads: "Stabilization or correction of spinal deformities without the use of fusion". FDA records list 123 510(k) clearances for K2m, Inc., from to . As of , FDA records show no recalls naming K161028.

Clearance record

Decision date
Received
(101 days to decision)
Product code
PGM Growing Rod System
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
K2m, Inc. 751 Miller Dr. SE, Leesburg VA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PGM

Trailing 12 months
1 clearance under product code PGM in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PGM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260