FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI
K Number: K983004
·
Decision Nov 25, 1998
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
12
Review Days
89
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
- CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI
- K Number
- K983004
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hayes Medical, Inc.
- Date Received
- August 28, 1998
- Decision Date
- November 25, 1998
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWH), ordered by most recent decision date.
NovoKnee (SteriKnee)
FDA 510(k)
FDA Class 2
·Orthopedic
Materialise TKA Guide System
FDA 510(k)
FDA Class 2
·Orthopedic
EMPOWR Knee
FDA 510(k)
FDA Class 2
·Orthopedic
ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom Infinia Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom® Total Knee System Titan PCK Components
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Hayes Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K070061 | 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT | Jan 31, 2007 | Substantially Equivalent |
| K062383 | UNISYN HA PLASMA MODULAR HIP | Dec 21, 2006 | Substantially Equivalent |
| K060635 | CONSENSUS ACETABULAR SHELL SYSTEM | Apr 28, 2006 | Substantially Equivalent |
| K030151 | CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM | Apr 10, 2003 | Substantially Equivalent |
| K030205 | CONSENSUS UNIPOLAR HEAD, COCR | Apr 1, 2003 | Substantially Equivalent |
| K021466 | CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE | Jul 24, 2002 | Substantially Equivalent |
| K020153 | CONSENSUS ACETABLAR SHELL, TI COATED | Apr 15, 2002 | Substantially Equivalent |
| K003649 | TRITON HIP SYSTEM | Feb 23, 2001 | Substantially Equivalent |
| K001456 | CONSENSUS KNEE SYSTEM | Aug 7, 2000 | Substantially Equivalent |
| K964395 | PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT | Jan 27, 1997 | Substantially Equivalent |