FDA 510(k)

해부학적 PEEK™ 목脊椎 합성 시스템 및 나노기술

K-번호: K230936 · 2023-06-02

결정일2023-06-02

제품 코드ODP

자문 위원회OR

결정Substantially Equivalent

기기 요약

Anatomic PEEK™ Cervical Fusion System with Nanotechnology is the device name listed in this FDA 510(k) record. The listed applicant is Nanovis, LLC. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K230936. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Anatomic PEEK™ Cervical Fusion System with Nanotechnology?

Anatomic PEEK™ Cervical Fusion System with Nanotechnology is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Nanovis, LLC. The 510(k) number is K230936.

When did Anatomic PEEK™ Cervical Fusion System with Nanotechnology receive FDA 510(k) clearance?

Anatomic PEEK™ Cervical Fusion System with Nanotechnology received FDA 510(k) clearance on 2023-06-02, under 510(k) number K230936.

Who is the listed applicant for Anatomic PEEK™ Cervical Fusion System with Nanotechnology?

The FDA 510(k) record lists Nanovis, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anatomic PEEK™ Cervical Fusion System with Nanotechnology?

The FDA product code for Anatomic PEEK™ Cervical Fusion System with Nanotechnology is ODP.

Nanovis, LLC를 신청인으로 등재한 기타 기록

K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology K203452Nano FortiFix® System K191822Nano FortiCore, FortiCore K171312FortiCore®K161485Nanovis Intervertebral Body Fusion System and Forticore(R)K160874Nanovis Intervertebral Body Fusion System and FortiCore®

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