SeaSpine® NewPort™ Spinal System
K号: K161535 · 2016-09-08
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器械摘要
SeaSpine® NewPort™ Spinal 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 2016-09-08 under 510(k) number K161535. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SeaSpine® NewPort™ Spinal System?
SeaSpine® NewPort™ Spinal System is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K161535.
When did SeaSpine® NewPort™ Spinal System receive FDA 510(k) clearance?
SeaSpine® NewPort™ Spinal System received FDA 510(k) clearance on 2016-09-08, under 510(k) number K161535.
Who is the listed applicant for SeaSpine® NewPort™ Spinal 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 SeaSpine® NewPort™ Spinal System?
The FDA product code for SeaSpine® NewPort™ Spinal System is NKB.
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列明SeaSpine Orthopedics Corporation为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SyK250908Virata Spinal Fixation SystemK243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsK242273Cove Putty, OsteoCove PuttyK241466Shoreline 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 SystemK240566Reef L Interbody System; WaveForm L Interbody System
相关器械（代码：NKB）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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