FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM
K Number: K061862
·
Decision Aug 28, 2006
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
70
Applicant Total
1
Review Days
59
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Basic Information
- Device Name
- AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM
- K Number
- K061862
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3690
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Axiom Orthopaedics, Inc.
- Date Received
- June 30, 2006
- Decision Date
- August 28, 2006
- Product Code
- HSD
- 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 |
|---|---|---|---|
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | FDA class 2 | Orthopedic |
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