FDA 510(k)
Substantially Equivalent
🇺🇸 United States
MECRON UNCEMENTED STRUCTURED STEM HIP
K Number: K854191
·
Decision Nov 13, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
14
Review Days
93
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Basic Information
- Device Name
- MECRON UNCEMENTED STRUCTURED STEM HIP
- K Number
- K854191
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Mecron Medical Products, Inc.
- Date Received
- August 12, 1985
- Decision Date
- November 13, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- OR
- Third Party
- N
Other Clearances by Mecron Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861138 | MASH DERMATOME | Apr 14, 1986 | 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 |
| K843449 | AUTODYNAMIC COMPRESSION HIP SCREW-PLATE | Oct 22, 1984 | Substantially Equivalent |
| K843553 | BONE PLATES | Oct 1, 1984 | Substantially Equivalent |
| K843554 | BONE SCREWS | Oct 1, 1984 | Substantially Equivalent |