FDA 510(k)

28mm/38D MDM X3 Insert for MDM Liner

K-번호: K233724 · 2024-03-11

신청자Howmedica Osteonics Corp., Dba Stryker Orthopaedics

결정일2024-03-11

제품 코드LZO

자문 위원회OR

결정Substantially Equivalent

기기 요약

28mm/38D MDM X3 Insert for MDM Liner is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2024-03-11 under 510(k) number K233724. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the 28mm/38D MDM X3 Insert for MDM Liner?

28mm/38D MDM X3 Insert for MDM Liner is a medical device that received FDA 510(k) clearance on 2024-03-11. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K233724.

When did 28mm/38D MDM X3 Insert for MDM Liner receive FDA 510(k) clearance?

28mm/38D MDM X3 Insert for MDM Liner received FDA 510(k) clearance on 2024-03-11, under 510(k) number K233724.

Who is the listed applicant for 28mm/38D MDM X3 Insert for MDM Liner?

The FDA 510(k) record lists Howmedica Osteonics Corp., Dba Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 28mm/38D MDM X3 Insert for MDM Liner?

The FDA product code for 28mm/38D MDM X3 Insert for MDM Liner is LZO.

Howmedica Osteonics Corp., Dba Stryker Orthopaedics를 신청인으로 등재한 기타 기록

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System 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 Component K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper K252044Triathlon® Total Knee System - Triathlon® Gold Femoral Components K251665Triathlon® Hinge Knee System

27개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.