FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLOBAL FX POROUS-COATED HUMERAL STEM
K Number: K011099
·
Decision Jul 6, 2001
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
34
Applicant Total
194
Review Days
86
Basic Information
- Device Name
- GLOBAL FX POROUS-COATED HUMERAL STEM
- K Number
- K011099
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3670
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DEPUY ORTHOPAEDICS, INC.
- Date Received
- April 11, 2001
- Decision Date
- July 6, 2001
- Product Code
- MBF
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | FDA class 2 | Orthopedic |
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