FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALLOFIX ANCHOR, 5.0 MM ANCHOR
K Number: K061498
·
Decision Jul 6, 2006
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
93
Applicant Total
24
Review Days
36
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ALLOFIX ANCHOR, 5.0 MM ANCHOR
- K Number
- K061498
- 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
- May 31, 2006
- Decision Date
- July 6, 2006
- Product Code
- JDW
- 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 |
|---|---|---|---|
| JDW | Pin, Fixation, Threaded | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDW), ordered by most recent decision date.
XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm
FDA 510(k)
FDA Class 2
·Orthopedic
Meduloc Intramedullary Fracture Fixation (IFF) System
FDA 510(k)
FDA Class 2
·Orthopedic
XT3 System
FDA 510(k)
FDA Class 2
·Orthopedic
MAVERICK Mini External Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
MAVERICK External Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Steinmann Pins and Kirschner Wires
FDA 510(k)
FDA Class 2
·Orthopedic
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 |