FDA 510(k)

MAXFRAME Multi-Axial Correction System (aka MAXFRAME)

K-번호: K211313 · 2021-05-25

결정일2021-05-25

제품 코드KTT

자문 위원회OR

결정Substantially Equivalent

기기 요약

MAXFRAME Multi-Axial Correction System (aka MAXFRAME) is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2021-05-25 under 510(k) number K211313. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the MAXFRAME Multi-Axial Correction System (aka MAXFRAME)?

MAXFRAME Multi-Axial Correction System (aka MAXFRAME) is a medical device that received FDA 510(k) clearance on 2021-05-25. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K211313.

When did MAXFRAME Multi-Axial Correction System (aka MAXFRAME) receive FDA 510(k) clearance?

MAXFRAME Multi-Axial Correction System (aka MAXFRAME) received FDA 510(k) clearance on 2021-05-25, under 510(k) number K211313.

Who is the listed applicant for MAXFRAME Multi-Axial Correction System (aka MAXFRAME)?

The FDA 510(k) record lists Synthes (USA) Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXFRAME Multi-Axial Correction System (aka MAXFRAME)?

The FDA product code for MAXFRAME Multi-Axial Correction System (aka MAXFRAME) is KTT.

Synthes (USA) Products, LLC를 신청인으로 등재한 기타 기록

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System K212943SyntheCel Dura Repair K210408DePuy Synthes Variable Angle Locking Patella Plating System K210205DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System K201346DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional

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