N1
K-Number: K232012 · 2023-11-28
Device Summary
Frequently Asked Questions
What is the N1?
N1 is a medical device that received FDA 510(k) clearance on 2023-11-28. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K232012.
When did N1 receive FDA 510(k) clearance?
N1 received FDA 510(k) clearance on 2023-11-28, under 510(k) number K232012.
Who is the listed applicant for N1?
The FDA 510(k) record lists Osstem Implant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for N1?
The FDA product code for N1 is EHD.
Other records listing Osstem Implant Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: EHD)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.