FDA 510(k)

Exceed® Biplanar Expandable Interbody System

K-번호: K261159 · 2026-05-29

결정일2026-05-29

제품 코드MAX

자문 위원회OR

결정Substantially Equivalent

기기 요약

Exceed® Biplanar Expandable Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K261159. 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 Exceed® Biplanar Expandable Interbody System?

Exceed® Biplanar Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is Spine Wave, Inc.. The 510(k) number is K261159.

When did Exceed® Biplanar Expandable Interbody System receive FDA 510(k) clearance?

Exceed® Biplanar Expandable Interbody System received FDA 510(k) clearance on 2026-05-29, under 510(k) number K261159.

Who is the listed applicant for Exceed® Biplanar Expandable Interbody System?

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

What is the FDA product code for Exceed® Biplanar Expandable Interbody System?

The FDA product code for Exceed® Biplanar Expandable Interbody System is MAX.

Spine Wave, Inc.를 신청인으로 등재한 기타 기록

K260286Dynamo™ Spinal Cement; Salvo® Spine System K243816Testa TP Pivoting Spacer System K251131Annex® 2 Adjacent Level System K243514Salvo® Robotic Navigation Instruments K240685Salvo® Spine System K231275Exceed™ Biplanar Expandable Interbody System

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