FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTIMA TPS CEMENTED STEM
K Number: K965198
·
Decision Jul 23, 1997
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
103
Applicant Total
10
Review Days
209
Basic Information
- Device Name
- ULTIMA TPS CEMENTED STEM
- K Number
- K965198
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- JOHNSON & JOHNSON INTERNATIONAL
- Date Received
- December 26, 1996
- Decision Date
- July 23, 1997
- 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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| K896828 | BIOCLUSIVE(R) ABSORBENT DRESSING | Nov 21, 1990 | Substantially Equivalent |
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| K895207 | BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM | Sep 28, 1989 | Substantially Equivalent |