FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM
K Number: K921113
·
Decision Oct 27, 1993
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
186
Review Days
597
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Basic Information
- Device Name
- EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM
- K Number
- K921113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Exactech, Inc.
- Date Received
- March 9, 1992
- Decision Date
- October 27, 1993
- Product Code
- LPH
- 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
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