Data / Medical devices / United States / Checkpoint Surgical Inc.
Checkpoint Surgical Inc.: FDA-registered device maker in Independence, OH, United States, 5 510(k) clearances
Checkpoint Surgical Inc. is registered with the FDA (registration 3012222873) in Independence, OH, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 26, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012222873
- Address
- 6050 Oak Tree Blvd Ste 360, Independence, OH, United States, 44131
- Owner or operator
- Checkpoint Surgical Inc. (10053637)
- Roles
- Specification developer
- First device listed
- December 26, 2016
- Registered through
- 2026
- Brand names listed
- Checkpoint, Checkpoint Edge Nerve Cutting Kit, Checkpoint Gemini, Checkpoint Guardian, Checkpoint Guardian Intraoperative Lead, Large, Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Small, Checkpoint Head & Neck and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cuff, Nerve | JXI | 2 | Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Specification developer | accessdata.fda.gov |
| Stimulator, Nerve | ETN | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 26, 2021 | K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large | ETN | Substantially Equivalent | Checkpoint Surgical | accessdata.fda.gov |
| May 31, 2019 | K190246 | NeuroShield | JXI | Substantially Equivalent | Monarch Bioimplants GmbH | accessdata.fda.gov |
| February 19, 2015 | K150005 | Checkpoint, Checkpoint Head & Neck | ETN | Substantially Equivalent | Ndi Medical, LLC | accessdata.fda.gov |
| October 28, 2009 | K092292 | CHECKPOINT | ETN | Substantially Equivalent | Ndi Medical, LLC | accessdata.fda.gov |
| July 12, 2006 | K061365 | CHECKPOINT WITH ACCUSTIM TECHNOLOGY | ETN | Substantially Equivalent | Ndi Medical, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 24, 2025 | 96387 | Class II | Ongoing | Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model/Catalog Number: REF# 9524 (Small) Product Description: The Checkpoint Guardian Intraoperative Leads a | Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confusing muscle responses, potentially compromising the effectiveness of the intended use as the surgeon could take an incor | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve
- All makers of Cuff, Nerve
- All makers of Instrument, Surgical, Non-Powered
Updated March 26, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.