FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Echo Bi-Metric Microplasty Line Extension
K Number: K150503
·
Decision Mar 25, 2015
Classifications
1
FEI Numbers
271
Registration Numbers
271
Same Product Code
551
Applicant Total
404
Review Days
27
Basic Information
- Device Name
- Echo Bi-Metric Microplasty Line Extension
- K Number
- K150503
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIOMET, INC.
- Date Received
- February 26, 2015
- Decision Date
- March 25, 2015
- Product Code
- LPH
- 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LPH), ordered by most recent decision date.
ONVOY Acetabular System
FDA 510(k)
FDA Class 2
·Orthopedic
Trinity EVO Acetabular Shell
FDA 510(k)
FDA Class 2
·Orthopedic
Mpact 3D Metal Augments II
FDA 510(k)
FDA Class 2
·Orthopedic
Initia T3 Acetabular Hemispherical Shell System
FDA 510(k)
FDA Class 2
·Orthopedic
Stryker Orthopaedics Hip Devices Labeling Update
FDA 510(k)
FDA Class 2
·Orthopedic
EMPHASYS Acetabular System
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 |
| K142933 | Biomet Tibial trays | Dec 23, 2014 | Substantially Equivalent |
| K143009 | Echo Bi-Metric Microplasty Hip System | Dec 18, 2014 | Substantially Equivalent |
| K140669 | G7 OSSEOTI ACETUBLAR SHELLS | Dec 11, 2014 | Substantially Equivalent |