FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
METATARSAL DECOMPRESSION IMPLANT, MODEL 100
K Number: K090127
·
Decision May 1, 2009
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
8
Review Days
100
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Basic Information
- Device Name
- METATARSAL DECOMPRESSION IMPLANT, MODEL 100
- K Number
- K090127
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3730
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Solana Surgical, LLC
- Date Received
- January 21, 2009
- Decision Date
- May 1, 2009
- Product Code
- KWD
- 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 |
|---|---|---|---|
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | FDA class 2 | Orthopedic |
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Other Clearances by Solana Surgical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K132594 | CROSSCHECK PLATING SYSTEM | Dec 13, 2013 | Substantially Equivalent |
| K131187 | LESSER METATARSAL HEAD IMPLANT SYSTEM | Oct 22, 2013 | Substantially Equivalent |
| K124045 | FUSEFORCE IMPLANT SYSTEM | Jul 10, 2013 | Substantially Equivalent |
| K122738 | GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET | Nov 7, 2012 | Substantially Equivalent |
| K120390 | SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET | Apr 10, 2012 | Substantially Equivalent |
| K120029 | HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET | Feb 6, 2012 | Substantially Equivalent |
| K113752 | METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET | Feb 6, 2012 | Substantially Equivalent |