FDA 510(k)

HAtetracell™-C Titanium Cervical IBF System

K-번호: K231899 · 2023-10-17

결정일2023-10-17

제품 코드ODP

자문 위원회OR

결정Substantially Equivalent

기기 요약

HAtetracell™-C Titanium Cervical IBF System is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2023-10-17 under 510(k) number K231899. 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 HAtetracell™-C Titanium Cervical IBF System?

HAtetracell™-C Titanium Cervical IBF System is a medical device that received FDA 510(k) clearance on 2023-10-17. The listed applicant is Innovasis, Inc.. The 510(k) number is K231899.

When did HAtetracell™-C Titanium Cervical IBF System receive FDA 510(k) clearance?

HAtetracell™-C Titanium Cervical IBF System received FDA 510(k) clearance on 2023-10-17, under 510(k) number K231899.

Who is the listed applicant for HAtetracell™-C Titanium Cervical IBF System?

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

What is the FDA product code for HAtetracell™-C Titanium Cervical IBF System?

The FDA product code for HAtetracell™-C Titanium Cervical IBF System is ODP.

Innovasis, Inc.를 신청인으로 등재한 기타 기록

K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)K250182Innovasis Navigation Instruments K241276Vector™ Pedicle Screw System K223511Excella Navigation Instruments K223510Matrix HA Fusion Porous Cervical IBF System K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF System

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