FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
The Simple Locking IntraMedullary (SLIM) System
K Number: K143355
·
Decision Jul 10, 2015
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
12
Review Days
228
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Basic Information
- Device Name
- The Simple Locking IntraMedullary (SLIM) System
- K Number
- K143355
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pega Medical, Inc.
- Date Received
- November 24, 2014
- Decision Date
- July 10, 2015
- Product Code
- HSB
- 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 |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | FDA class 2 | Orthopedic |
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| K131591 | FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) | Nov 27, 2013 | Substantially Equivalent |
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| K090440 | HINGE PEDIATRIC PLATING SYSTEM | May 20, 2009 | Substantially Equivalent |
| K041393 | FASSIER-DUVAL TELSCOPIC IM SYSTEM | Aug 17, 2004 | Substantially Equivalent |