FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
K Number: K013935
·
Decision Dec 13, 2001
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
45
Review Days
15
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Basic Information
- Device Name
- ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
- K Number
- K013935
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sulzer Orthopedics, Inc.
- Date Received
- November 28, 2001
- Decision Date
- December 13, 2001
- Product Code
- LZO
- 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 |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | FDA class 2 | Orthopedic |
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Other Clearances by Sulzer Orthopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K022985 | ASCENDENT ACETABULAR SYSTEM | Dec 5, 2002 | Substantially Equivalent |
| K021578 | NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE | Aug 9, 2002 | Substantially Equivalent |
| K020713 | MS-30 LATERAL FEMORAL STEM | May 14, 2002 | Substantially Equivalent |
| K013031 | MOST OPTIONS SYSTEM | Dec 7, 2001 | Substantially Equivalent |
| K012739 | CONVERGE ACETABULAR SYSTEM | Nov 14, 2001 | Substantially Equivalent |
| K012961 | SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM | Oct 18, 2001 | Substantially Equivalent |
| K011954 | SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE | Sep 19, 2001 | Substantially Equivalent |
| K010839 | CLS VARUS STEM/CLS 135 STEM | Apr 18, 2001 | Substantially Equivalent |
| K003758 | ALLOFIT ACETABULAR SYSTEM | Mar 7, 2001 | Substantially Equivalent |
| K003801 | ANATOMICAL PRESS-FIT HUMERAL STEM | Feb 28, 2001 | Substantially Equivalent |