Simplex P Speedset with Tobramycin Bone Cement
FDA 510(k) K063857 · Howmedica Osteonics Corp.
510(k) numberK063857
Submission
- Device name
- Simplex P Speedset with Tobramycin Bone Cement
- Applicant
- Howmedica Osteonics Corp.
Mahwah, NJ, US - Received
- December 28, 2006
- Decision date
- February 26, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBB – Bone Cement, Antibiotic
- 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 with Tobramycin Bone Cement cleared by the FDA?
Simplex P Speedset with Tobramycin Bone Cement (K063857) received a 510(k) decision of Substantially Equivalent on February 26, 2007, 60 days after the submission was received.
What is the product code of K063857?
The FDA product code is MBB – Bone Cement, Antibiotic, a Class II (moderate risk) device regulated under 21 CFR 888.3027.