FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIMPLEX P BONE CEMENT
K Number: K062553
·
Decision Jan 8, 2007
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
71
Applicant Total
24
Review Days
131
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
- SIMPLEX P BONE CEMENT
- K Number
- K062553
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Orthopaedics
- Date Received
- August 30, 2006
- Decision Date
- January 8, 2007
- Product Code
- LOD
- 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 |
|---|---|---|---|
| LOD | Bone Cement | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LOD), ordered by most recent decision date.
Refobacin Bone Cement R (110034355)
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRUM GV Bone Cement
FDA 510(k)
FDA Class 2
·Orthopedic
OSTEOPAL® V
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRUM® GV Bone Cement
FDA 510(k)
FDA Class 2
·Orthopedic
Bone Cement Genta, Bone Cement HV, Bone Cement LV
FDA 510(k)
FDA Class 2
·Orthopedic
Bone Cement-Normal Viscosity
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Stryker Orthopaedics
| K Number | Device Name | ||
|---|---|---|---|
| K211703 | Insignia Hip Stem | Aug 16, 2021 | Substantially Equivalent |
| K191414 | EXETER Centralizer, EXETER 2.5mm Plug | Aug 28, 2019 | Substantially Equivalent |
| K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | Mar 19, 2018 | Substantially Equivalent |
| K173849 | Triathlon Total Knee System | Feb 2, 2018 | Substantially Equivalent |
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Oct 30, 2017 | Substantially Equivalent |
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | May 25, 2016 | Substantially Equivalent |
| K151264 | Restoration Anatomic Shell | Aug 10, 2015 | Substantially Equivalent |
| K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach | Feb 9, 2015 | Substantially Equivalent |
| K143393 | Triathlon Tritanium Cone Augments | Jan 13, 2015 | Substantially Equivalent |
| K142462 | Restoration Anatomic Shell | Nov 14, 2014 | Substantially Equivalent |