FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPROCESSED EBI EXTERNAL FIXATION DEVICES
K Number: K012645
·
Decision Jun 24, 2002
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
36
Review Days
315
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Basic Information
- Device Name
- REPROCESSED EBI EXTERNAL FIXATION DEVICES
- K Number
- K012645
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alliance Medical Corp.
- Date Received
- August 13, 2001
- Decision Date
- June 24, 2002
- Product Code
- KTW
- 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 |
|---|---|---|---|
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTW), ordered by most recent decision date.
PK High Tibial Osteotomy Correction System
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AOS Anterolateral Proximal Humeral Plate
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Phantom Small Bone Intramedullary Nail System
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AOS Anterolateral Proximal Humeral Plate
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ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)
FDA 510(k)
FDA Class 2
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AOS PROXIMAL HUMERAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Alliance Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K060648 | REPROCESSED PHACOEMULSIFICATION TIPS | Mar 19, 2007 | Substantially Equivalent |
| K061045 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | Aug 31, 2006 | Substantially Equivalent |
| K060049 | REPROCESSED COMPRESSION SLEEVES | Feb 24, 2006 | Substantially Equivalent |
| K060091 | ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES | Feb 17, 2006 | Substantially Equivalent |
| K053316 | REPROCESSED COMPRESSION SLEEVES | Feb 13, 2006 | Substantially Equivalent |
| K052918 | REPROCESSED EXTERNAL FIXATION DEVICES | Jan 27, 2006 | Substantially Equivalent |
| K052603 | REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS | Nov 16, 2005 | Substantially Equivalent |
| K052414 | REPROCESSED ELECTROPHYSIOLOGY CATHETER | Nov 16, 2005 | Substantially Equivalent |
| K052064 | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | Aug 25, 2005 | Substantially Equivalent |
| K052062 | ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES | Aug 25, 2005 | Substantially Equivalent |