FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPLEX CEMENT RESTRICTOR SYSTEM
K Number: K943378
·
Decision Sep 23, 1994
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
36
Applicant Total
65
Review Days
72
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Basic Information
- Device Name
- IMPLEX CEMENT RESTRICTOR SYSTEM
- K Number
- K943378
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Implex Corp.
- Date Received
- July 13, 1994
- Decision Date
- September 23, 1994
- Product Code
- LZN
- 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 |
|---|---|---|---|
| LZN | Cement Obturator | FDA class 2 | General, Plastic Surgery |
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| 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 |