FDA Registration Inactive 🇺🇸 United States

CHECKPOINT SURGICAL INC.

· Expires 2026
Products
3
Proprietary Names
12
Establishment Types
1
Classifications
3

Registration Details

Registration Name
CHECKPOINT SURGICAL INC.
Status
Inactive
Expiry Year
2026
Initial Importer
No
Address
6650 W Snowville Rd Ste I
City
Brecksville
State
OH
ZIP
44141
Country
US

Regulatory Submissions

510(k) Number
K061365

Owner / Operator

Firm Name
Checkpoint Surgical Inc.
Operator Number
10053637
Address
6050 Oak Tree Blvd., Suite 360
City
Independence
State
OH
Postal Code
44131
Country
US
Correspondent
Matt Hildebrand

Products

Device Name Product Code
Stimulator, Nerve ETN
Cuff, Nerve JXI
Instrument, Surgical, Non-Powered HAO

Proprietary Names

Checkpoint Stimulator Checkpoint Checkpoint Head & Neck NeuroShield ProVeil Checkpoint Guardian Checkpoint Gemini Checkpoint Probe Extension Checkpoint Guardian Intraoperative Lead, Medium Checkpoint Guardian Intraoperative Lead, Large Checkpoint Guardian Intraoperative Lead, Small Checkpoint Edge Nerve Cutting Kit

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility