Simplex X

FDA 510(k) K032945 · Stryker Corp.

Substantially Equivalent

510(k) numberK032945

Submission

Device name
Simplex X
Applicant
Stryker Corp.
Kalamazoo, MI, US
Received
September 22, 2003
Decision date
May 25, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

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

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Questions and answers

When was Simplex X cleared by the FDA?

Simplex X (K032945) received a 510(k) decision of Substantially Equivalent on May 25, 2004, 246 days after the submission was received.

What is the product code of K032945?

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