FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASCENDENT ACETABULAR SYSTEM
K Number: K022985
·
Decision Dec 5, 2002
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
45
Review Days
87
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ASCENDENT ACETABULAR SYSTEM
- K Number
- K022985
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sulzer Orthopedics, Inc.
- Date Received
- September 9, 2002
- Decision Date
- December 5, 2002
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZO), ordered by most recent decision date.
Z1 Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
Avenir® Müller Stem; Avenir Complete Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
implantcast Packaging System Update
FDA 510(k)
FDA Class 2
·Orthopedic
implaFit® short stems
FDA 510(k)
FDA Class 2
·Orthopedic
Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)
FDA 510(k)
FDA Class 2
·Orthopedic
Coated hip implants
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Sulzer Orthopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021578 | NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE | Aug 9, 2002 | Substantially Equivalent |
| K020713 | MS-30 LATERAL FEMORAL STEM | May 14, 2002 | Substantially Equivalent |
| K013935 | ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS | Dec 13, 2001 | 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 |