FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APEX KNEE MODULAR TIBIA SYSTEM
K Number: K131472
·
Decision Oct 8, 2013
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
21
Review Days
139
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Basic Information
- Device Name
- APEX KNEE MODULAR TIBIA SYSTEM
- K Number
- K131472
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Omni Life Science, Inc.
- Date Received
- May 22, 2013
- Decision Date
- October 8, 2013
- Product Code
- JWH
- 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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
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Other Clearances by Omni Life Science, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K191765 | OMNI TiN Coated Apex Knee System | Sep 25, 2019 | Substantially Equivalent |
| K152919 | OMNI Skirted Heads | Mar 10, 2016 | Substantially Equivalent |
| K112891 | APEX REVISION KNEE SYSTEMS | Feb 29, 2012 | Substantially Equivalent |
| K113242 | APEX ARC HIP STEM | Jan 5, 2012 | Substantially Equivalent |
| K111062 | APEX KNEE SYSTEM, APEX ALL POLY TIBIA | Jul 13, 2011 | Substantially Equivalent |
| K111193 | APEX ARC HIP STEM | Jun 27, 2011 | Substantially Equivalent |
| K111184 | APEX PS KNEE SYSTEM - PS-C INSERT | Jun 22, 2011 | Substantially Equivalent |
| K110947 | APEX K1 HIP STEM | Jun 16, 2011 | Substantially Equivalent |
| K102578 | APEX PS KNEE SYSTEM | Mar 25, 2011 | Substantially Equivalent |
| K101976 | INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET | Sep 14, 2010 | Substantially Equivalent |