Alliance Partners, LLC
Avon Lake, OH, US
Alliance Partners, LLC appears in FDA device records in Avon Lake, OH. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Alliance Partners, LLC between 2011 and 2020. The busiest year on record is 2012, with 3. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2012 | 3 |
| 2014 | 3 |
| 2015 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201521 | Medina Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K173128 | Alamo® C | ODP | Substantially Equivalent | |
| K141123 | ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM | GWO | Substantially Equivalent | |
| K141993 | NAKOMA ACP | KWQ | Substantially Equivalent | |
| K140303 | ALAMO T | MAX | Substantially Equivalent | |
| K133321 | ALAMO C | ODP | Substantially Equivalent | |
| K120401 | ALAMO T | MAX | Substantially Equivalent | |
| K122047 | ALAMO P | MAX | Substantially Equivalent | |
| K121181 | SWANNSHIDI BONE MARROW ASPIRATION NEEDLE | KNW | Substantially Equivalent | |
| K112361 | ALAMO C | ODP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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. | Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw advancing through the plate during implantation. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain