510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231611Substantially Equivalent

HOLO Portal™ Surgical Guidance System

Surgalign Spine Technologies, Deerfield IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231611 is the FDA 510(k) clearance record for HOLO Portal™ Surgical Guidance System, a class II device, cleared for Surgalign Spine Technologies on under FDA product code SBF (Orthopedic Augmented Reality). FDA's definition for product code SBF reads: "An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as “augmented reality” stereoscopic images to intraoperatively...". FDA records list 3 510(k) clearances for Surgalign Spine Technologies, from to . As of , FDA records show no recalls naming K231611.

Clearance record

Decision date
Received
(90 days to decision)
Product code
SBF Orthopedic Augmented Reality
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Surgalign Spine Technologies 520 Lake Cook Rd. Suite 315, Deerfield IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SBF

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