510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230927Substantially Equivalent

OptiMesh Multiplanar Expandable Interbody Fusion System

Spineology, Inc., Saint Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230927 is the FDA 510(k) clearance record for OptiMesh Multiplanar Expandable Interbody Fusion System, a class II device, cleared for Spineology, Inc. on under FDA product code OQB (Intervertebral Body Graft Containment Device). FDA's definition for product code OQB reads: "An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is...". FDA records list 54 510(k) clearances for Spineology, Inc., from to . As of , FDA records show no recalls naming K230927.

Clearance record

Decision date
Received
(212 days to decision)
Product code
OQB Intervertebral Body Graft Containment Device
Regulation
21 CFR 888.3085
Device class
Class II
Review panel
Orthopedic
Applicant
Spineology, Inc. 7800 3rd St. N., Saint Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OQB

Trailing 12 months
1 clearance under product code OQB in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OQB, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260