FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TORNIER TOTAL ELBOW PROSTHESIS
K Number: K000003
·
Decision Oct 2, 2000
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
28
Applicant Total
44
Review Days
273
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
- TORNIER TOTAL ELBOW PROSTHESIS
- K Number
- K000003
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3150
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tornier
- Date Received
- January 3, 2000
- Decision Date
- October 2, 2000
- Product Code
- JDC
- 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 |
|---|---|---|---|
| JDC | Prosthesis, Elbow, Constrained, Cemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDC), ordered by most recent decision date.
TEMA Elbow System
FDA 510(k)
FDA Class 2
·Orthopedic
Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow
FDA 510(k)
FDA Class 2
·Orthopedic
Comprehensive SRS/Nexel Elbow
FDA 510(k)
FDA Class 2
·Orthopedic
Zimmer Nexel Total Elbow Ulnar Cement Diverter
FDA 510(k)
FDA Class 2
·Orthopedic
ZIMMER NEXEL TOTAL ELBOW
FDA 510(k)
FDA Class 2
·Orthopedic
DISCOVERY ELBOW - X-SMALL
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Tornier
| K Number | Device Name | ||
|---|---|---|---|
| K112144 | AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS | Mar 13, 2012 | Substantially Equivalent |
| K111970 | KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT | Feb 23, 2012 | Substantially Equivalent |
| K111902 | AEQUALIS SHOULDER SYSTEM | Nov 3, 2011 | Substantially Equivalent |
| K094013 | HLS KNEETEC SYSTEM | May 5, 2011 | Substantially Equivalent |
| K100142 | AEQUALIS REVERSED SHOULDER PROSTHESIS | May 6, 2010 | Substantially Equivalent |
| K091870 | TORNIER, PITON FIXATION IMPLANT SYSTEM | Sep 21, 2009 | Substantially Equivalent |
| K090076 | SALTO TALARIS TOTAL ANKLE PROSTHESIS | Mar 17, 2009 | Substantially Equivalent |
| K082754 | AEQUALIS HUMERAL NAIL SYSTEM | Jan 27, 2009 | Substantially Equivalent |
| K082120 | AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS | Oct 24, 2008 | Substantially Equivalent |
| K081059 | AEQUALIS REVERSED SHOULDER PROSTHESIS | Jul 17, 2008 | Substantially Equivalent |