FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPACER G TEMPORARY HIP PROSTHESIS
K Number: K031841
·
Decision Jan 22, 2004
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
106
Applicant Total
186
Review Days
220
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Basic Information
- Device Name
- SPACER G TEMPORARY HIP PROSTHESIS
- K Number
- K031841
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Exactech, Inc.
- Date Received
- June 16, 2003
- Decision Date
- January 22, 2004
- Product Code
- KWL
- 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 |
|---|---|---|---|
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | FDA class 2 | Orthopedic |
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