FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IP-XS COMPRESSION NAIL SYSTEM
K Number: K032548
·
Decision Sep 10, 2003
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
38
Review Days
23
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Basic Information
- Device Name
- IP-XS COMPRESSION NAIL SYSTEM
- K Number
- K032548
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Plus Orthopedics
- Date Received
- August 18, 2003
- Decision Date
- September 10, 2003
- 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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Other Clearances by Plus Orthopedics
| K Number | Device Name | ||
|---|---|---|---|
| K032126 | PROMOS SHOULDER | Jan 8, 2004 | Substantially Equivalent |
| K033763 | MODIFICATION TO SLIM GLIDING NAIL SYSTEM | Dec 18, 2003 | Substantially Equivalent |
| K032709 | MODULAR PLUS HIP STEM | Sep 23, 2003 | Substantially Equivalent |
| K032215 | VKS/TC-PLUS REVISION KNEE | Aug 8, 2003 | Substantially Equivalent |
| K032052 | UC-PLUS SOLUTION UNICONDYLAR KNEE | Jul 25, 2003 | Substantially Equivalent |
| K031165 | PLUS ORTHOPEDICS CEMENTED HIP STEM | Jun 6, 2003 | Substantially Equivalent |
| K030971 | MODIFICATION TO MODULAR PLUS REVISION STEM | Apr 24, 2003 | Substantially Equivalent |
| K024134 | UNI HIP STEM | Jan 15, 2003 | Substantially Equivalent |
| K023667 | RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE | Dec 24, 2002 | Substantially Equivalent |
| K023416 | MODIFICATION TO VKS KNEE SYSTEM | Nov 8, 2002 | Substantially Equivalent |