KYPHON (R) HV-R(R) Bone Cement

FDA 510(k) K150460 · Medtronic Sofamor Danck USA, Inc.

Substantially Equivalent

510(k) numberK150460

Submission

Device name
KYPHON (R) HV-R(R) Bone Cement
Applicant
Medtronic Sofamor Danck USA, Inc.
Memphis, TN, US
Received
February 23, 2015
Decision date
April 28, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NDN – Cement, Bone, Vertebroplasty
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3027
Specialty
Orthopedic
Implant
Yes

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K221697Injection Pin (KIP(02031-02061) (03031-03061))NDN · Traditional Slk Ortho, LLC03/03/2023SE
K223294SpineJack® Expansion KitNDN · Traditional Stryker Instruments12/20/2022SE
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Questions and answers

When was KYPHON (R) HV-R(R) Bone Cement cleared by the FDA?

KYPHON (R) HV-R(R) Bone Cement (K150460) received a 510(k) decision of Substantially Equivalent on April 28, 2015, 64 days after the submission was received.

What is the product code of K150460?

The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.