FDA 510(k)

WaveForm L System, WaveForm TO System, WaveForm TA System

K-번호: K213420 · 2022-05-04

결정일2022-05-04

제품 코드MAX

자문 위원회OR

결정Substantially Equivalent

기기 요약

WaveForm L System, WaveForm TO System, WaveForm TA System is the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2022-05-04 under 510(k) number K213420. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the WaveForm L System, WaveForm TO System, WaveForm TA System?

WaveForm L System, WaveForm TO System, WaveForm TA System is a medical device that received FDA 510(k) clearance on 2022-05-04. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K213420.

When did WaveForm L System, WaveForm TO System, WaveForm TA System receive FDA 510(k) clearance?

WaveForm L System, WaveForm TO System, WaveForm TA System received FDA 510(k) clearance on 2022-05-04, under 510(k) number K213420.

Who is the listed applicant for WaveForm L System, WaveForm TO System, WaveForm TA System?

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

What is the FDA product code for WaveForm L System, WaveForm TO System, WaveForm TA System?

The FDA product code for WaveForm L System, WaveForm TO System, WaveForm TA System is MAX.

SeaSpine Orthopedics Corporation를 신청인으로 등재한 기타 기록

K253420Admiral ACP 시스템; Explorer TO 시스템; Laminoplasty 시스템; Manta Ray TDF Spacer; Meridian Interbody 시스템; Meridian Anterior Plate 시스템; Reef L Interbody 시스템; Reef TO/TA 시스템; Regatta Lateral 시스템; Regatta Lateral Plate 시스템; Shoreline ACS Interbody 시스템; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody 시스템; Vu Mesh; WaveForm A Interbody 시스템; WaveForm C Interbody 시스템; WaveForm L Interbody 시스템; WaveForm TA Interbody 시스템; WaveForm TO Interbody 시스템 K250908Virata Spinal Fixation System K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments K242273Cove Putty, OsteoCove Putty K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System K240566Reef L Interbody System; WaveForm L Interbody System

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