Spinal System— 510(k) K142576

Clearance details

Applicant

Eisertech, LLC

Product code

Code NKB

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2014-09-12

Decision date

2015-02-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Poway, CA, US

• K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD2026-09-04
• K253943 — Tiger 2 System2026-07-24
• K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)2026-07-24
• K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System2026-07-14
• K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD2026-07-01

• K192768 — Temporary Fixation Pins2019-12-26
• K190565 — Cervical Plate2019-05-31
• K140348 — INTERBODY CAGE2015-04-23
• K122444 — CERVICAL CAGE2012-08-30
• K113170 — CERVICAL PLATE2012-04-06

Death

27

Injury

5,033

Malfunction

4,140

Total

9,200

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-2070-2015 — Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.Class II·Terminated·Exactech, Inc.·20150521

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142576.