FDA 510(k)

Daytona® Small Stature Growth Rod Conversion Set

K-번호: K193224 · 2020-02-13

결정일2020-02-13

제품 코드PGM

자문 위원회OR

결정Substantially Equivalent

기기 요약

Daytona® Small Stature Growth Rod Conversion Set 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 2020-02-13 under 510(k) number K193224. The device is classified under product code PGM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Daytona® Small Stature Growth Rod Conversion Set?

Daytona® Small Stature Growth Rod Conversion Set is a medical device that received FDA 510(k) clearance on 2020-02-13. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K193224.

When did Daytona® Small Stature Growth Rod Conversion Set receive FDA 510(k) clearance?

Daytona® Small Stature Growth Rod Conversion Set received FDA 510(k) clearance on 2020-02-13, under 510(k) number K193224.

Who is the listed applicant for Daytona® Small Stature Growth Rod Conversion Set?

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 Daytona® Small Stature Growth Rod Conversion Set?

The FDA product code for Daytona® Small Stature Growth Rod Conversion Set is PGM.

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