FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
K Number: K970779
·
Decision May 9, 1997
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
36
Applicant Total
178
Review Days
66
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Basic Information
- Device Name
- OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
- K Number
- K970779
- 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
- Osteonics Corp.
- Date Received
- March 4, 1997
- Decision Date
- May 9, 1997
- 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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|---|---|---|---|
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| K990203 | OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS | Feb 18, 1999 | Substantially Equivalent |
| K990158 | OSTEONICS COMBINATION SCREW RING/BLOCKER | Feb 1, 1999 | Substantially Equivalent |
| K984302 | OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS | Dec 18, 1998 | Substantially Equivalent |
| K984353 | OSTEO 9MM IC TIBIAL NAIL | Dec 16, 1998 | Substantially Equivalent |
| K983502 | OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM | Dec 16, 1998 | Substantially Equivalent |