FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K Number: K013772
·
Decision Dec 3, 2001
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
56
Applicant Total
13
Review Days
20
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Basic Information
- Device Name
- MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
- K Number
- K013772
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Howmedica Osteonics
- Date Received
- November 13, 2001
- Decision Date
- December 3, 2001
- Product Code
- LXT
- 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 |
|---|---|---|---|
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | FDA class 2 | Orthopedic |
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|---|---|---|---|
| K120578 | ACCOLADE II HIP STEM | Mar 29, 2012 | Substantially Equivalent |
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| K063423 | TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT | Jan 22, 2007 | Substantially Equivalent |
| K033258 | BONESAVE BONE VOID FILLER | Mar 9, 2004 | Substantially Equivalent |
| K032855 | STRYKER SPINE MAPS SYSTEM | Dec 10, 2003 | Substantially Equivalent |
| K031702 | REFLEX ANTERIOR CERVICAL PLATE SYSTEM | Aug 8, 2003 | Substantially Equivalent |
| K031435 | BONESOURCE BVF | Aug 4, 2003 | Substantially Equivalent |
| K031217 | GMRS PRESS FIT STEMS WITH PUREFIX HA | May 23, 2003 | Substantially Equivalent |
| K022461 | S2 FEMORAL NAIL | Aug 22, 2002 | Substantially Equivalent |
| K022160 | XIA SPINAL SYSTEM | Aug 1, 2002 | Substantially Equivalent |