K2M Navigation Instruments— 510(k) K171321

Clearance details

Applicant

K2m

Product code

Code OLO

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2017-05-04

Decision date

2017-08-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Leesburg, VA, US

• K262506 — Remex Spine Surgery Navigation - Universal Instruments2026-08-20
• K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))2026-07-30
• K261205 — SPINEART Navigation Instrument System2026-07-29
• K261024 — TMINI Miniature Robotic System2026-07-24
• K262121 — Ion-L Navigated Instruments2026-07-24

• K182182 — YUKON OCT Spinal System2018-11-15
• K181890 — Brainlab Compatible K2M Navigation Instruments2018-11-09
• K172941 — CASCADIA Interbody System2018-02-12
• K171556 — K2M Navigation Instruments2018-01-16
• K173508 — Everest Spinal System2018-01-09

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-0052-2020 — K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instruments include an additional feature on their shafts that enable surgeon users to combine them with non-K2M navigation systems as part of their standard surgical technique.Class II·Terminated·K2M, Inc·20161202

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171321.