FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00
K Number: K014154
·
Decision Mar 18, 2002
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
13
Review Days
90
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
- VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00
- K Number
- K014154
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vilex, Inc.
- Date Received
- December 18, 2001
- Decision Date
- March 18, 2002
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HWC), ordered by most recent decision date.
VEOFIX Snap Off Screw
FDA 510(k)
FDA Class 2
·Orthopedic
CoLink® & CoLag® Non-Sterile Screws
FDA 510(k)
FDA Class 2
·Orthopedic
TriMed Compression Screws
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex Beaming System
FDA 510(k)
FDA Class 2
·Orthopedic
OSSIOfiber® Threaded Trimmable Fixation Nail
FDA 510(k)
FDA Class 2
·Orthopedic
TITAN Nail; APTUS K-Wire System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Vilex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K132820 | VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES | Jul 23, 2014 | Substantially Equivalent |
| K112837 | VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) | Oct 9, 2012 | Substantially Equivalent |
| K102413 | FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL | Nov 14, 2011 | Substantially Equivalent |
| K102401 | HEMI IMPLANT; MINI HEMI IMPLANT | Jul 20, 2011 | Substantially Equivalent |
| K070052 | MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION | Mar 28, 2007 | Substantially Equivalent |
| K052196 | VILEX X-FIX | Nov 22, 2005 | Substantially Equivalent |
| K041287 | VILEX BONE PLATE SYSTEM | Aug 5, 2004 | Substantially Equivalent |
| K041289 | TALUS OF VILEX (TOV) | Aug 5, 2004 | Substantially Equivalent |
| K023684 | CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365 | Mar 1, 2004 | Substantially Equivalent |
| K991151 | VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW | Apr 26, 1999 | Substantially Equivalent |