Ascent Porous Open Box PS Component/Ascent Posterior Stabalized (PS) Distal Femoral Pegs
FDA 510(k) K041872 · Biomet Manufacturing Corp
510(k) numberK041872
Submission
- Device name
- Ascent Porous Open Box PS Component/Ascent Posterior Stabalized (PS) Distal Femoral Pegs
- Applicant
- Biomet Manufacturing Corp
Warsaw, IN, US - Received
- July 9, 2004
- Decision date
- September 8, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3565
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Ascent Porous Open Box PS Component/Ascent Posterior Stabalized (PS) Distal Femoral Pegs cleared by the FDA?
Ascent Porous Open Box PS Component/Ascent Posterior Stabalized (PS) Distal Femoral Pegs (K041872) received a 510(k) decision of Substantially Equivalent on September 8, 2004, 61 days after the submission was received.
What is the product code of K041872?
The FDA product code is MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3565.