FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MBARESORB IMPLANT
K Number: K051611
·
Decision Sep 6, 2005
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
19
Review Days
81
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Basic Information
- Device Name
- MBARESORB IMPLANT
- K Number
- K051611
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kinetikos Medical, Inc.
- Date Received
- June 17, 2005
- Decision Date
- September 6, 2005
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Kinetikos Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K061749 | ECLIPSE TOTAL ANKLE IMPLANT | Nov 22, 2006 | Substantially Equivalent |
| K061465 | KMI CEMENT RESTRICTOR IMPLANT | Oct 5, 2006 | Unknown |
| K041461 | KMI DISTAL VOLAR RADIUS PLATE SYSTEM | Aug 16, 2004 | Substantially Equivalent |
| K032806 | KATALYST RADIAL HEAD IMPLANT | Apr 16, 2004 | Substantially Equivalent |
| K040356 | KOMPRESSOR SCREW SYSTEM | Mar 1, 2004 | Substantially Equivalent |
| K024233 | KOMPRESSOR SCREW SYSTEM | Feb 6, 2003 | Substantially Equivalent |
| K030037 | UNIVERSAL TOTAL WRIST SYSTEM | Feb 5, 2003 | Substantially Equivalent |
| K023770 | K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) | Dec 12, 2002 | Substantially Equivalent |
| K020554 | MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM | May 3, 2002 | Substantially Equivalent |
| K991873 | KMI WRIST FUSION SYSTEM | Aug 17, 1999 | Substantially Equivalent |