K2M COCR ROD— 510(k) K080792

Name: FDA 510(k) clearance K080792
Creator: U.S. Food and Drug Administration
Published: 2008-04-08

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K080792 for K2M COCR ROD, Substantially Equivalent on 2008-04-08. Applicant: K2m, Inc.. Device class: 2.

Clearance details

Applicant: K2m, Inc.
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2008-03-20
Decision date: 2008-04-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Leesburg, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNI

view all

K171497 — Mikron Spinal Fixation System2017-10-12
K160731 — LumFix Spinal Fixation Sytem2016-10-04
K151458 — Double Medical Universal Spine System2016-08-22
K153273 — MySpine Pedicle Screw Placement Guides - LP2016-06-29
K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System2016-04-04

More clearances from K2m, Inc.

view all

K260546 — Q Pedicle Instruments2026-03-17
K253545 — Vulcan Spinal System2026-02-10
K252873 — Q Interbody Instruments2026-02-06
K211320 — CAPRI Corpectomy Cage System2022-02-24
K202528 — Cannulated Power Driver Attachment2020-10-26

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.