FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MERETE LOCKING BONE PLATE SYSTEM II
K Number: K102688
·
Decision Dec 3, 2010
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
24
Review Days
77
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Basic Information
- Device Name
- MERETE LOCKING BONE PLATE SYSTEM II
- K Number
- K102688
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Merete Medical GmbH
- Date Received
- September 17, 2010
- Decision Date
- December 3, 2010
- 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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|---|---|---|---|
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| K141377 | BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD | Nov 21, 2014 | Substantially Equivalent |
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| K132226 | METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT | Aug 9, 2013 | Substantially Equivalent |
| K123619 | INTRABLOCK BIOBALL HIP SYSTEM (IBS) | May 24, 2013 | Substantially Equivalent |
| K130400 | MERETEC CS, CORTICAL SCREWS | Apr 5, 2013 | Substantially Equivalent |
| K120787 | MERETE LOCKING BONE PLATE SYSTEM III | Nov 27, 2012 | Substantially Equivalent |