FDA 510(k)

United Orthopedic Knee Patient Specific Instrumentation

K-번호: K230850 · 2023-12-20

결정일2023-12-20

제품 코드OOG

자문 위원회OR

결정Substantially Equivalent

기기 요약

United Orthopedic Knee Patient Specific Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Enhatch, Inc.. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K230850. The device is classified under product code OOG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the United Orthopedic Knee Patient Specific Instrumentation?

United Orthopedic Knee Patient Specific Instrumentation is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Enhatch, Inc.. The 510(k) number is K230850.

When did United Orthopedic Knee Patient Specific Instrumentation receive FDA 510(k) clearance?

United Orthopedic Knee Patient Specific Instrumentation received FDA 510(k) clearance on 2023-12-20, under 510(k) number K230850.

Who is the listed applicant for United Orthopedic Knee Patient Specific Instrumentation?

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

What is the FDA product code for United Orthopedic Knee Patient Specific Instrumentation?

The FDA product code for United Orthopedic Knee Patient Specific Instrumentation is OOG.

공식 출처

FDA 데이터베이스에서 보기 →

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

United Orthopedic Knee Patient Specific Instrumentation

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: OOG)

공식 출처