510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201961Substantially Equivalent

IlluminOss Photodynamic Bone Stabilization System

Illuminoss Medical Inc., East Providence RI / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201961 is the FDA 510(k) clearance record for IlluminOss Photodynamic Bone Stabilization System, a class II device, cleared for Illuminoss Medical, Inc. on under FDA product code QAD (Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated). FDA's definition for product code QAD reads: "Is a device intended to be implanted that consists of a polymeric balloon that is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures. The balloon is infused with a liquid monomer that causes the...". FDA records list 6 510(k) clearances for Illuminoss Medical, Inc., from to . As of , FDA records show no recalls naming K201961.

Clearance record

Decision date
Received
(30 days to decision)
Product code
QAD Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
Regulation
21 CFR 888.3023
Device class
Class II
Review panel
Orthopedic
Applicant
Illuminoss Medical, Inc. 993 Waterman Ave., East Providence RI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QAD

Trailing 12 months

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

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