FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISCOVERY ELBOW
K Number: K013042
·
Decision Oct 10, 2001
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
28
Applicant Total
34
Review Days
30
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Basic Information
- Device Name
- DISCOVERY ELBOW
- K Number
- K013042
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3150
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Orthopedics, Inc.
- Date Received
- September 10, 2001
- Decision Date
- October 10, 2001
- Product Code
- JDC
- 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 |
|---|---|---|---|
| JDC | Prosthesis, Elbow, Constrained, Cemented | FDA class 2 | Orthopedic |
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| K023357 | ARCPM 1050 RESIN-HIPS | Nov 6, 2002 | Substantially Equivalent |