FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOMET NTS FEMORAL COMPONENTS
K Number: K920161
·
Decision Apr 13, 1992
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
560
Applicant Total
404
Review Days
90
Basic Information
- Device Name
- BIOMET NTS FEMORAL COMPONENTS
- K Number
- K920161
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BIOMET, INC.
- Date Received
- January 14, 1992
- Decision Date
- April 13, 1992
- Product Code
- JDI
- 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDI), ordered by most recent decision date.
Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
FDA 510(k)
FDA Class 2
·Orthopedic
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
FDA 510(k)
FDA Class 2
·Orthopedic
Stryker Orthopaedics Hip Systems Labeling Update
FDA 510(k)
FDA Class 2
·Orthopedic
Global Modular Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
FDA 510(k)
FDA Class 2
·Orthopedic
C-Stem AMT LE Prosthesis
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by BIOMET, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K161592 | Persona Partial Knee System | Nov 3, 2016 | Substantially Equivalent |
| K161166 | StageOne Select Cement Spacer Molds for Temporary Hip Replacement | Sep 8, 2016 | Substantially Equivalent |
| K153657 | Vanguard XP Knee System | May 10, 2016 | Substantially Equivalent |
| K152621 | OSS/Arcos IM Total Femur Rod | Oct 14, 2015 | Substantially Equivalent |
| K150850 | Refobacin Bone Cement R | Jul 16, 2015 | Substantially Equivalent |
| K150867 | Affixus Tibial Nailing System | Jun 10, 2015 | Substantially Equivalent |
| K150522 | G7 Dual Mobility System | May 1, 2015 | Substantially Equivalent |
| K150503 | Echo Bi-Metric Microplasty Line Extension | Mar 25, 2015 | Substantially Equivalent |
| K142933 | Biomet Tibial trays | Dec 23, 2014 | Substantially Equivalent |
| K143009 | Echo Bi-Metric Microplasty Hip System | Dec 18, 2014 | Substantially Equivalent |