FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTODYNAMIC COMPRESSION HIP SCREW-PLATE
K Number: K843449
·
Decision Oct 22, 1984
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
14
Review Days
47
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Basic Information
- Device Name
- AUTODYNAMIC COMPRESSION HIP SCREW-PLATE
- K Number
- K843449
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Mecron Medical Products, Inc.
- Date Received
- September 5, 1984
- Decision Date
- October 22, 1984
- Product Code
- KTT
- 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | FDA class 2 | Orthopedic |
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Other Clearances by Mecron Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861138 | MASH DERMATOME | Apr 14, 1986 | Substantially Equivalent |
| K854191 | MECRON UNCEMENTED STRUCTURED STEM HIP | Nov 13, 1985 | Substantially Equivalent |
| K844775 | EFFNER-EYE CAUTERY WITH BATTERY HANDLE | Aug 12, 1985 | Substantially Equivalent |
| K844774 | EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS | Apr 22, 1985 | Substantially Equivalent |
| K844488 | MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS | Mar 12, 1985 | Substantially Equivalent |
| K844487 | MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR | Feb 19, 1985 | Substantially Equivalent |
| K844486 | MECRON MRC-HEADLESS FEMORAL COMPONENT | Feb 19, 1985 | Substantially Equivalent |
| K844773 | EFF-EFFNER BULBS | Jan 8, 1985 | Substantially Equivalent |
| K843553 | BONE PLATES | Oct 1, 1984 | Substantially Equivalent |
| K843554 | BONE SCREWS | Oct 1, 1984 | Substantially Equivalent |