FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
K Number: K033384
·
Decision Nov 19, 2003
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
53
Applicant Total
65
Review Days
27
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
- THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
- K Number
- K033384
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Implex Corp.
- Date Received
- October 23, 2003
- Decision Date
- November 19, 2003
- Product Code
- JDK
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| JDK | Prosthesis, Hip, Cement Restrictor | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDK), ordered by most recent decision date.
Mectaplug PE II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KMI CEMENT RESTRICTOR IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIFE SPINE CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPINAL USA CEMENT RESTRICTOR SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTERBODY INNOVATIONS CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 |
| K040630 | TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ | Sep 30, 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 |
| 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 |