FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE
K Number: K070598
·
Decision Jul 26, 2007
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
200
Applicant Total
10
Review Days
146
Basic Information
- Device Name
- MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE
- K Number
- K070598
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEMOMETAL TECHNOLOGIES
- Date Received
- March 2, 2007
- Decision Date
- July 26, 2007
- Product Code
- HTY
- 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 |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | FDA class 2 | Orthopedic |
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Other Clearances by MEMOMETAL TECHNOLOGIES
| K Number | Device Name | ||
|---|---|---|---|
| K112197 | MEMOMETAL INTRA-MEDULLARY BONE FASTENER | Nov 17, 2011 | Substantially Equivalent |
| K101930 | MEMOMETAL NAVIS BONE PLATING SYSTEM | Mar 15, 2011 | Substantially Equivalent |
| K102072 | MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE) | Nov 3, 2010 | Substantially Equivalent |
| K093820 | SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 | May 19, 2010 | Substantially Equivalent |
| K083447 | MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50 | Feb 6, 2009 | Substantially Equivalent |
| K071941 | MEMOMETAL BONE ANCHORS | Dec 4, 2007 | Substantially Equivalent |
| K070039 | MEMOMETAL FIXOS SCREWS | Mar 21, 2007 | Substantially Equivalent |
| K070033 | MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10 | Mar 19, 2007 | Substantially Equivalent |
| K070031 | MEMOMETAL MEMORY STAPLES | Mar 19, 2007 | Substantially Equivalent |