510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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DEN240038Unknown

Oxiplex®

Fziomed, Inc., San Luis Obispo CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN240038 is the FDA 510(k) clearance record for Oxiplex®, a class II device, cleared for Fziomed, Inc. on under FDA product code QVL (Absorbable Gel For Intraoperative Use In Spine Surgery). FDA's definition for product code QVL reads: "This device is an absorbable gel implant for intraoperative use in spinal procedures that is applied to nerve roots after hemostasis has been achieved and prior to closure. The device is intended as an adjunct to the surgical procedure to...". FDA records list 2 510(k) clearances for Fziomed, Inc., from to . As of , FDA records show no recalls naming DEN240038.

Clearance record

Decision date
Received
(330 days to decision)
Product code
QVL Absorbable Gel For Intraoperative Use In Spine Surgery
Regulation
21 CFR 888.3047
Device class
Class II
Review panel
Orthopedic
Applicant
Fziomed, Inc. 231 Bonetti Dr., San Luis Obispo CA
Third party review
No

Clearances, product code QVL

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