NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS— 510(k) K140454

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

2014-02-24

Decision date

2014-05-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Memphis, TN, US

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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 →

• Z-2363-2023 — CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006KClass II·Ongoing·Medtronic Sofamor Danek USA, Inc·20230712

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140454.