FDA 510(k)

앞쪽 척추 트러스 시스템 (STS) 인터빗 브릿지 장치

K-번호: K170851 · 2017-08-07

결정일2017-08-07

제품 코드MAX

자문 위원회OR

결정Substantially Equivalent

기기 요약

Anterior Spine Truss System (STS) Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is 4Web, Inc.. It received FDA 510(k) clearance on 2017-08-07 under 510(k) number K170851. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Anterior Spine Truss System (STS) Interbody Fusion Device?

Anterior Spine Truss System (STS) Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2017-08-07. The listed applicant is 4Web, Inc.. The 510(k) number is K170851.

When did Anterior Spine Truss System (STS) Interbody Fusion Device receive FDA 510(k) clearance?

Anterior Spine Truss System (STS) Interbody Fusion Device received FDA 510(k) clearance on 2017-08-07, under 510(k) number K170851.

Who is the listed applicant for Anterior Spine Truss System (STS) Interbody Fusion Device?

The FDA 510(k) record lists 4Web, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anterior Spine Truss System (STS) Interbody Fusion Device?

The FDA product code for Anterior Spine Truss System (STS) Interbody Fusion Device is MAX.

4Web, Inc.를 신청인으로 등재한 기타 기록

K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)K200002앞쪽 척추 트러스 시스템 – 독립형 (ASTS-SA) 인터빗 브릿지 장치 K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)K190926Hammertoe Truss System (HTS)K172294Osteotomy Truss System (OTS)

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