Cofield Total Shoulder System
FDA 510(k) K070565 · Smith & Nephew, Inc.
510(k) numberK070565
Submission
- Device name
- Cofield Total Shoulder System
- Applicant
- Smith & Nephew, Inc.
Memphis, TN, US - Received
- February 28, 2007
- Decision date
- May 18, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 Cofield Total Shoulder System cleared by the FDA?
Cofield Total Shoulder System (K070565) received a 510(k) decision of Substantially Equivalent on May 18, 2007, 79 days after the submission was received.
What is the product code of K070565?
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.