Infinity OCT System, PASS OCT® Spinal System— 510(k) K210449

Clearance details

Applicant

Medtronic

Product code

Code NKG

Device class

Class 2

Regulation

21 CFR 888.3075

Advisory panel

Orthopedic

Date received

2021-02-16

Decision date

2021-03-18

Decision

Substantially Equivalent

Clearance type

Special

Location

Memphis, TN, US

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• K253129 — Infinity OCT System2025-10-24

• K253530 — Trexon Monofilament Synthetic Absorbable Suture2026-05-28
• K251744 — Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter2026-01-16
• K233433 — Sphere-9Dx Diagnostic Catheter (AFR-00009)2024-08-07
• K240190 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated2024-02-23
• K223494 — CD Horizon Spinal System2023-01-23

Death

15

Injury

1,090

Malfunction

529

Total

1,634

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 →