FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALLOFIX ANCHOR
K Number: K053339
·
Decision Mar 16, 2006
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
24
Review Days
105
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Basic Information
- Device Name
- ALLOFIX ANCHOR
- K Number
- K053339
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Musculoskeletal Transplant Foundation
- Date Received
- December 1, 2005
- Decision Date
- March 16, 2006
- Product Code
- GAT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Musculoskeletal Transplant Foundation
| K Number | Device Name | ||
|---|---|---|---|
| K181633 | MTF Pre-Sutured Tendon | Mar 15, 2019 | Substantially Equivalent |
| 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 |