FDA 510(k)

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment

K-번호: K190991 · 2019-08-15

신청자Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)

결정일2019-08-15

제품 코드MBH

자문 위원회OR

결정Substantially Equivalent

기기 요약

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp. (Aka Stryker Orthopaedics). It received FDA 510(k) clearance on 2019-08-15 under 510(k) number K190991. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment?

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment is a medical device that received FDA 510(k) clearance on 2019-08-15. The listed applicant is Howmedica Osteonics Corp. (Aka Stryker Orthopaedics). The 510(k) number is K190991.

When did Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment receive FDA 510(k) clearance?

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment received FDA 510(k) clearance on 2019-08-15, under 510(k) number K190991.

Who is the listed applicant for Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment?

The FDA 510(k) record lists Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment?

The FDA product code for Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment is MBH.

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