FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALLOFIX PUSH-IN ANCHOR
K Number: K070347
·
Decision May 11, 2007
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
24
Review Days
94
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Basic Information
- Device Name
- ALLOFIX PUSH-IN ANCHOR
- K Number
- K070347
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Musculoskeletal Transplant Foundation
- Date Received
- February 6, 2007
- Decision Date
- May 11, 2007
- 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 Musculoskeletal Transplant Foundation
| K Number | Device Name | ||
|---|---|---|---|
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| K121313 | MTF NEW BONE VOID FILLER | Jan 11, 2013 | Substantially Equivalent |
| K120479 | MTF FASCIA | Nov 8, 2012 | Substantially Equivalent |
| K113167 | MTF NEW BONE VOILD FILLER | Jan 24, 2012 | Substantially Equivalent |
| K110003 | MTF NEW BONE VOID FILLER | Oct 13, 2011 | Substantially Equivalent |
| K103795 | DBX DEMINERALIZED BONE MATRIX PUTTY | Apr 13, 2011 | Substantially Equivalent |
| K103784 | DBX DEMINERALIZED BONE MATRIX PUTTY | Apr 13, 2011 | Substantially Equivalent |
| K091217 | DBX DEMINERALIZED BONE MATRIX PUTTY | Oct 2, 2009 | Substantially Equivalent |
| K091218 | DBX DEMINERALIZED BONE MATRIX PUTTY | Sep 28, 2009 | Substantially Equivalent |
| K080399 | DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE | Oct 10, 2008 | Substantially Equivalent |