Navigated T2 STRATOSPHERE Inserters and Navigated Templates— 510(k) K191039

Clearance details

Applicant

Medtronic Sofamor Danek USA, Inc.

Product code

Code OLO

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2019-04-19

Decision date

2019-08-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Memphis, TN, US

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• K262121 — Ion-L Navigated Instruments2026-07-24

• K253011 — Catalyft PL Expandable Interbody System2026-07-17
• K261020 — Symmetrix L Spinal System2026-07-14
• K253656 — OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System2026-06-05
• K260216 — CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System2026-04-21
• K254165 — Infinity OCT System2026-01-21

Death

11

Injury

2,799

Malfunction

11,105

Other

1

Total

13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →