Bio-Modular Shoulder System with Hydroxyapatite (Ha) Coated Glenoid Components
FDA 510(k) K043100 · Biomet, Inc.
510(k) numberK043100
Submission
- Device name
- Bio-Modular Shoulder System with Hydroxyapatite (Ha) Coated Glenoid Components
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- November 9, 2004
- Decision date
- February 17, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Bio-Modular Shoulder System with Hydroxyapatite (Ha) Coated Glenoid Components cleared by the FDA?
Bio-Modular Shoulder System with Hydroxyapatite (Ha) Coated Glenoid Components (K043100) received a 510(k) decision of Substantially Equivalent on February 17, 2005, 100 days after the submission was received.
What is the product code of K043100?
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.