Modification to Vertebroplastic Radiopaque Bone Cement

FDA 510(k) K071927 · Depuy Spine, A Johnson & Johnson Company

Substantially Equivalent

510(k) numberK071927

Submission

Device name
Modification to Vertebroplastic Radiopaque Bone Cement
Applicant
Depuy Spine, A Johnson & Johnson Company
Raynham, MA, US
Received
July 12, 2007
Decision date
November 21, 2007
Decision
Substantially Equivalent (SESE)
Type
Special 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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Questions and answers

When was Modification to Vertebroplastic Radiopaque Bone Cement cleared by the FDA?

Modification to Vertebroplastic Radiopaque Bone Cement (K071927) received a 510(k) decision of Substantially Equivalent on November 21, 2007, 132 days after the submission was received.

What is the product code of K071927?

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