FDA 510(k)

CoCr Head

K-번호: K211047 · 2023-01-10

결정일2023-01-10

제품 코드LPH

자문 위원회OR

결정Substantially Equivalent

기기 요약

CoCr Head is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2023-01-10 under 510(k) number K211047. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the CoCr Head?

CoCr Head is a medical device that received FDA 510(k) clearance on 2023-01-10. The listed applicant is Zimmer GmbH. The 510(k) number is K211047.

When did CoCr Head receive FDA 510(k) clearance?

CoCr Head received FDA 510(k) clearance on 2023-01-10, under 510(k) number K211047.

Who is the listed applicant for CoCr Head?

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

What is the FDA product code for CoCr Head?

The FDA product code for CoCr Head is LPH.

Zimmer GmbH를 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.

K200814Affixus(R) Natural Nail(R) System Humeral Nail K200112Zimmer Hip Joint Replacement K193099해부학적 어깨 시스템 K193050Alloclassic Zweymuller SL 대퇴골 끝, Alloclassic Zweymuller SL 기울기 대퇴골 끝 K193030Avenir Muller Stem, Avenir Cemented Hip Stem K192236Fitmore Hip Stem

19개 장치 모두 보기 →

관련 기기 (코드: LPH)

K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 3D Metal FoamMedacta International S.A.K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® Complete Hip StemBiomet, Inc.

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