Global FX Porous-Coated Humeral Stem
FDA 510(k) K011099 · DePuy Orthopaedics, Inc.
510(k) numberK011099
Submission
- Device name
- Global FX Porous-Coated Humeral Stem
- Applicant
- DePuy Orthopaedics, Inc.
Warsaw, IN, US - Received
- April 11, 2001
- Decision date
- July 6, 2001
- 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 FX Porous-Coated Humeral Stem cleared by the FDA?
Global FX Porous-Coated Humeral Stem (K011099) received a 510(k) decision of Substantially Equivalent on July 6, 2001, 86 days after the submission was received.
What is the product code of K011099?
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.