FDA 510(k)

Peridot Spinal Interbody System

K-번호: K213980 · 2022-03-15

결정일2022-03-15

제품 코드ODP

자문 위원회OR

결정Substantially Equivalent

기기 요약

Peridot Spinal Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Gbs Commonwealth Co., Ltd.. It received FDA 510(k) clearance on 2022-03-15 under 510(k) number K213980. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Peridot Spinal Interbody System?

Peridot Spinal Interbody System is a medical device that received FDA 510(k) clearance on 2022-03-15. The listed applicant is Gbs Commonwealth Co., Ltd.. The 510(k) number is K213980.

When did Peridot Spinal Interbody System receive FDA 510(k) clearance?

Peridot Spinal Interbody System received FDA 510(k) clearance on 2022-03-15, under 510(k) number K213980.

Who is the listed applicant for Peridot Spinal Interbody System?

The FDA 510(k) record lists Gbs Commonwealth Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Peridot Spinal Interbody System?

The FDA product code for Peridot Spinal Interbody System is ODP.

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