Global Ap Porous Coated Humeral Stem
FDA 510(k) K063652 · DePuy Orthopaedics, Inc.
510(k) numberK063652
Submission
- Device name
- Global Ap Porous Coated Humeral Stem
- Applicant
- DePuy Orthopaedics, Inc.
Warsaw, IN, US - Received
- December 8, 2006
- Decision date
- February 1, 2007
- 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 Global Ap Porous Coated Humeral Stem cleared by the FDA?
Global Ap Porous Coated Humeral Stem (K063652) received a 510(k) decision of Substantially Equivalent on February 1, 2007, 55 days after the submission was received.
What is the product code of K063652?
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.