FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
K Number: K040630
·
Decision Sep 30, 2004
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
65
Review Days
204
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Basic Information
- Device Name
- TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
- K Number
- K040630
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Implex Corp.
- Date Received
- March 10, 2004
- Decision Date
- September 30, 2004
- 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 |
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Other Clearances by Implex Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K051978 | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT | Sep 23, 2005 | Substantially Equivalent |
| K051196 | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1 | Jun 17, 2005 | Substantially Equivalent |
| K040487 | TRABECULAR METAL KNEE SYSTEM AUGMENTS | Dec 21, 2004 | Substantially Equivalent |
| K040756 | THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX | Jul 14, 2004 | Substantially Equivalent |
| K031962 | NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS | Jan 8, 2004 | Substantially Equivalent |
| K033384 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ | Nov 19, 2003 | Substantially Equivalent |
| K032527 | HEDROCEL VERTEBRAL BODY REPLACEMENT | Oct 31, 2003 | Substantially Equivalent |
| K032344 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 | Oct 2, 2003 | Substantially Equivalent |
| K031449 | MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION | Sep 23, 2003 | Substantially Equivalent |
| K032282 | MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM | Aug 21, 2003 | Substantially Equivalent |