FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
K Number: K080980
·
Decision May 6, 2008
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
158
Applicant Total
186
Review Days
29
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Basic Information
- Device Name
- EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
- K Number
- K080980
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Exactech, Inc.
- Date Received
- April 7, 2008
- Decision Date
- May 6, 2008
- Product Code
- MEH
- 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 |
|---|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | FDA class 2 | Orthopedic |
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