FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
K Number: K051616
·
Decision Sep 6, 2005
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
33
Review Days
81
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Basic Information
- Device Name
- VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
- K Number
- K051616
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vanguard Medical Concepts, Inc.
- Date Received
- June 17, 2005
- Decision Date
- September 6, 2005
- Product Code
- KTT
- 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | FDA class 2 | Orthopedic |
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Other Clearances by Vanguard Medical Concepts, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K053051 | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | Dec 22, 2005 | Substantially Equivalent |
| K051180 | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES | Jul 22, 2005 | Substantially Equivalent |
| K051043 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Jun 6, 2005 | Substantially Equivalent |
| K050763 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Jun 1, 2005 | Substantially Equivalent |
| K043198 | VANGUARD REPROCESSED ARTHROSCOPIC WANDS | May 27, 2005 | Substantially Equivalent |
| K043253 | VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS | Apr 8, 2005 | Substantially Equivalent |
| K043594 | VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES | Mar 31, 2005 | Substantially Equivalent |
| K043225 | VANGUARD REPROCESSED ULTRASONIC SCALPEL | Mar 22, 2005 | Substantially Equivalent |
| K043315 | VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL | Mar 22, 2005 | Substantially Equivalent |
| K040751 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Mar 10, 2005 | Substantially Equivalent |