FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNISYN PLUS HIP STEM
K Number: K120595
·
Decision Oct 12, 2012
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
80
Applicant Total
17
Review Days
227
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
- UNISYN PLUS HIP STEM
- K Number
- K120595
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Consensus Orthopedics, Inc.
- Date Received
- February 28, 2012
- Decision Date
- October 12, 2012
- Product Code
- LWJ
- 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 |
|---|---|---|---|
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LWJ), ordered by most recent decision date.
TRINITY ACETABULAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NOVATION CFS PRESS-FIT AND CEMENTED STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
U2 HIP STEM, TI PLASMA SPRAY
FDA 510(k)
FDA Class 2
·Orthopedic
UNISYN HA PLASMA MODULAR HIP
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Consensus Orthopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K170344 | Tahoe Uni Knee System | Oct 5, 2017 | Substantially Equivalent |
| K163167 | CKS Plus Knee System | Aug 9, 2017 | Substantially Equivalent |
| K160515 | PS2 Knee System | Dec 19, 2016 | Substantially Equivalent |
| K143725 | Consensus Knee System Modular Tibial Baseplate | Mar 4, 2015 | Substantially Equivalent |
| K133919 | CONSENSUS VITALITE TIBIAL INSERT | Jul 14, 2014 | Substantially Equivalent |
| K141043 | CS2 MULTI-HOLE ACETABULAR SHELL | May 19, 2014 | Substantially Equivalent |
| K130652 | VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT | Dec 17, 2013 | Substantially Equivalent |
| K122512 | CS2 HIP SYSTEM | Nov 5, 2012 | Substantially Equivalent |
| K121935 | TAPERSET HIP SMALL STEMS | Sep 10, 2012 | Substantially Equivalent |
| K121263 | TAPER SET HIP SYSTEM RDP STEM | May 22, 2012 | Substantially Equivalent |