Synthes Epoca Shoulder Prosthesis System
FDA 510(k) K083439 · Synthes (Usa)
510(k) numberK083439
Submission
- Device name
- Synthes Epoca Shoulder Prosthesis System
- Applicant
- Synthes (Usa)
West Chester, PA, US - Received
- November 20, 2008
- Decision date
- February 5, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBF – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3670
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Synthes Epoca Shoulder Prosthesis System cleared by the FDA?
Synthes Epoca Shoulder Prosthesis System (K083439) received a 510(k) decision of Substantially Equivalent on February 5, 2009, 77 days after the submission was received.
What is the product code of K083439?
The FDA product code is MBF – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3670.