NILE Alternative Fixation Spinal System— 510(k) K160208

Name: FDA 510(k) clearance K160208
Creator: U.S. Food and Drug Administration
Published: 2016-03-18

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K160208 for NILE Alternative Fixation Spinal System, Substantially Equivalent on 2016-03-18. Applicant: K2m, Inc.. Device class: 2.

Clearance details

Applicant: K2m, Inc.
Product code: Code OWI
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2016-01-28
Decision date: 2016-03-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Leesburg, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OWI

view all

K261374 — LigaPASS System2026-05-27
K253615 — Invictus Bands System2026-03-25
K222097 — OLYMPIC Deformity Band System2023-05-04
K230565 — HILINE Fixation System2023-04-20
K213659 — LigaPASS 2.0 Ligament Augmentation System2022-05-24

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

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