Simplex P Speedset Bone Cement
FDA 510(k) K053198 · Howmedica Osteonics Corp.
510(k) numberK053198
Submission
- Device name
- Simplex P Speedset Bone Cement
- Applicant
- Howmedica Osteonics Corp.
Mahwah, NJ, US - Received
- November 16, 2005
- Decision date
- January 26, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 P Speedset Bone Cement cleared by the FDA?
Simplex P Speedset Bone Cement (K053198) received a 510(k) decision of Substantially Equivalent on January 26, 2006, 71 days after the submission was received.
What is the product code of K053198?
The FDA product code is LOD – Bone Cement, a Class II (moderate risk) device regulated under 21 CFR 888.3027.