510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131784Substantially Equivalent

Range Spinal System

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

K131784 is the FDA 510(k) clearance record for RANGE SPINAL SYSTEM, a class II device, cleared for K2m, Inc. on under FDA product code OSH (Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis). FDA's definition for product code OSH reads: "Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis". FDA records list 123 510(k) clearances for K2m, Inc., from to . As of , FDA records show no recalls naming K131784.

Clearance record

Decision date
Received
(73 days to decision)
Product code
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
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 OSH

Trailing 12 months

FDA records hold no clearances under product code OSH in the trailing twelve months.

FDA records show no clearances under product code OSH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OSH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260