FDA 510(k)

EDEN Peek Cage

K-번호: K201793 · 2021-09-13

결정일2021-09-13

제품 코드ODP

자문 위원회OR

결정Substantially Equivalent

기기 요약

EDEN Peek Cage is the device name listed in this FDA 510(k) record. The listed applicant is Jmt Co., Ltd.. It received FDA 510(k) clearance on 2021-09-13 under 510(k) number K201793. 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 EDEN Peek Cage?

EDEN Peek Cage is a medical device that received FDA 510(k) clearance on 2021-09-13. The listed applicant is Jmt Co., Ltd.. The 510(k) number is K201793.

When did EDEN Peek Cage receive FDA 510(k) clearance?

EDEN Peek Cage received FDA 510(k) clearance on 2021-09-13, under 510(k) number K201793.

Who is the listed applicant for EDEN Peek Cage?

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

What is the FDA product code for EDEN Peek Cage?

The FDA product code for EDEN Peek Cage is ODP.

Jmt Co., Ltd.를 신청인으로 등재한 기타 기록

관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.

K241410EDEN ControlCath K230762EDEN Spinal Fixation MIS System K201788EDEN Spinal Fixation System

관련 기기 (코드: ODP)

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

공식 출처

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