FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMI IMPLANT; MINI HEMI IMPLANT
K Number: K102401
·
Decision Jul 20, 2011
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
13
Review Days
330
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Basic Information
- Device Name
- HEMI IMPLANT; MINI HEMI IMPLANT
- K Number
- K102401
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3730
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vilex, Inc.
- Date Received
- August 24, 2010
- Decision Date
- July 20, 2011
- Product Code
- KWD
- 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 |
|---|---|---|---|
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWD), ordered by most recent decision date.
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restor3d MTP Implant
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BioPoly Great Toe Hemiarthroplasty Implant
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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 |
| 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 |
| K014154 | VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00 | Mar 18, 2002 | Substantially Equivalent |
| K991151 | VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW | Apr 26, 1999 | Substantially Equivalent |