FDA 510(k)

LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.

Número K: K231636 · 2023-06-27

Data da decisão2023-06-27

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. is the device name listed in this FDA 510(k) record. The listed applicant is L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2023-06-27 under 510(k) number K231636. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.?

LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. is a medical device that received FDA 510(k) clearance on 2023-06-27. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K231636.

When did LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. receive FDA 510(k) clearance?

LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. received FDA 510(k) clearance on 2023-06-27, under 510(k) number K231636.

Who is the listed applicant for LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.?

The FDA 510(k) record lists L&K BIOMED Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.?

The FDA product code for LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. is NKB.

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Outros registros que listam L&K BIOMED Co., Ltd. como candidato(a)

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Fonte oficial

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