FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
ETEX HA HIP REPLACEMENT SYSTEM
K Number: K935696
·
Decision Jul 22, 1994
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
158
Applicant Total
18
Review Days
234
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Basic Information
- Device Name
- ETEX HA HIP REPLACEMENT SYSTEM
- K Number
- K935696
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Etex Corp.
- Date Received
- November 30, 1993
- Decision Date
- July 22, 1994
- 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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