NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Inter
Summary
Nu Vasive, Incorporated received 510(k) clearance for NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System, a ODP device. Cleared on 2023-07-11.
Details
Source
510(k) Clearance
External ID
K231735
Action Date
2023-07-11
Status
Special
Category
device
Product Code
ODP
Product Description
NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System. Product code: ODP.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Nu Vasive, Incorporated has received 11 total clearances in our database.
Nu Vasive, Incorporated has 11 FDA actions in our database, including 11 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Nu Vasive, Incorporated have FDA actions?
Nu Vasive, Incorporated has 11 FDA actions in our database, including 0 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K231735" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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