NAKOMA ACP— 510(k) K141993

Clearance details

Applicant

Alliance Partners, LLC

Product code

Code KWQ

Device class

Class 2

Regulation

21 CFR 888.3060

Advisory panel

Orthopedic

Date received

2014-07-22

Decision date

2014-11-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Memphis, TN, US

• K261309 — Palisades Buttress Plate System2026-07-16
• K252776 — ARIES Anterior Cervical Plate Systems2026-05-14
• K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
• K260570 — corra cervical plating system2026-04-22
• K260697 — VyPlate Anterior Cervical Plate System2026-03-27

• K201521 — Medina Anterior Cervical Plate System2020-08-06
• K173128 — Alamo® C2018-03-22
• K141123 — ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM2015-02-27
• K140303 — ALAMO T2014-04-21
• K133321 — ALAMO C2014-01-09

Death

8

Injury

1,212

Malfunction

1,233

Total

2,453

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-1989-2015 — Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with the following indications: Degenerative Disk Disease, Trauma, Tumors, Deformities or curvatures, Psuedoarthrosis, Failed previous fusions, Spondylolistesis, and Spinal Stenosis.Class II·Terminated·Alliance Partners LLC·20150609

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141993.