510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191039Substantially Equivalent

Navigated T2 STRATOSPHERE Inserters and Navigated Templates

Medtronic Sofamor Danek USA Inc, Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191039 is the FDA 510(k) clearance record for Navigated T2 STRATOSPHERE Inserters and Navigated Templates, a class II device, cleared for Medtronic Sofamor Danek USA, Inc. on under FDA product code OLO (Orthopedic Stereotaxic Instrument). FDA's definition for product code OLO reads: "Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW". FDA records list 182 510(k) clearances for Medtronic Sofamor Danek USA, Inc., from to . As of , FDA records show no recalls naming K191039.

Clearance record

Decision date
Received
(129 days to decision)
Product code
OLO Orthopedic Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Pl., Memphis TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLO

Trailing 12 months
44 clearances under product code OLO in the twelve months to October 2026, February 2026 the highest month at 10.
Show the numbers
Monthly 510(k) clearances under FDA product code OLO, trailing twelve months
MonthClearances
November 20252
December 20254
January 20262
February 202610
March 20267
April 20262
May 20265
June 20265
July 20266
August 20261
September 20260
October 20260