FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPROCESSED EXTERNAL FIXATION DEVICE
K Number: K012634
·
Decision Jun 24, 2002
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
11
Review Days
315
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Basic Information
- Device Name
- REPROCESSED EXTERNAL FIXATION DEVICE
- K Number
- K012634
- 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, Inc.
- 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
·Orthopedic
AOS PROXIMAL HUMERAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Alliance Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051438 | VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) | Apr 4, 2006 | Substantially Equivalent |
| K050518 | REPROCESSED PHACOEMUISIFICATION TIPS | Sep 23, 2005 | Substantially Equivalent |
| K030187 | REPROCESSED ELECTROPHYSIOLOGY CATHETER | Sep 24, 2003 | Substantially Equivalent |
| K021654 | REPROCESSED COMPRESSION SLEEVE | Feb 5, 2003 | Substantially Equivalent |
| K012630 | REPROCESSED LINVATEC ARTHROSCOPIC BURS | Nov 9, 2001 | Substantially Equivalent |
| K012611 | REPROCESSED DYONICS ARTHROSCOPIC SHAVERS | Nov 7, 2001 | Substantially Equivalent |
| K012613 | REPROCSSED LINVATEC SHAVERS | Nov 7, 2001 | Substantially Equivalent |
| K990198 | AMIB7 | Jun 29, 1999 | Substantially Equivalent |
| K951976 | ECHO. AKHO | Jul 26, 1996 | Substantially Equivalent |
| K931091 | DISPOSABLE AMA STERILE DRAPE SHEET, CAT. NO. 5252 | Feb 3, 1994 | Substantially Equivalent |