510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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DEN180012Unknown

LOADPRO™ Intraoperative Rod Strain Sensor

Intellirod Spine, Inc., Akron OH / Direct, Unknown
FDA source (opens on fda.gov)

DEN180012 is the FDA 510(k) clearance record for LOADPRO™ Intraoperative Rod Strain Sensor, a class II device, cleared for Intellirod Spine, Inc. on under FDA product code QFP (Intraoperative Orthopedic Strain Sensor). FDA's definition for product code QFP reads: "A strain sensor device is an adjunct tool intended to measure strain on an orthopedic implant in the intraoperative setting only. The device is not intended to provide diagnostic information or influence clinical decision-making". FDA records list one 510(k) clearance for Intellirod Spine, Inc. As of , FDA records show no recalls naming DEN180012.

Clearance record

Decision date
Received
(379 days to decision)
Product code
QFP Intraoperative Orthopedic Strain Sensor
Regulation
21 CFR 888.3090
Device class
Class II
Review panel
Orthopedic
Applicant
Intellirod Spine, Inc. 554f White Pond Dr., Akron OH
Third party review
No

Clearances, product code QFP

Trailing 12 months

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

FDA records show no clearances under product code QFP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QFP, 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