FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
INION OTPS BIODEGRADABLE FIXATON SYSTEM
K Number: K030900
·
Decision Jun 19, 2003
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
23
Review Days
87
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Basic Information
- Device Name
- INION OTPS BIODEGRADABLE FIXATON SYSTEM
- K Number
- K030900
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inion , Ltd.
- Date Received
- March 24, 2003
- Decision Date
- June 19, 2003
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Inion , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K071810 | INION SPINAL GRAFT CONTAINMENT SYSTEM | Jul 11, 2008 | Unknown |
| K063410 | INION CPS/OTPS FREEDOMPLATE | Jan 23, 2007 | Substantially Equivalent |
| K062617 | MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM | Oct 4, 2006 | Substantially Equivalent |
| K060393 | INION HEXALON BIODEGRADABLE ACL/PCL SCREW | Mar 13, 2006 | Substantially Equivalent |
| K051821 | INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM | Nov 25, 2005 | Substantially Equivalent |
| K052624 | INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE | Nov 16, 2005 | Substantially Equivalent |
| K052444 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM | Sep 20, 2005 | Substantially Equivalent |
| K051341 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059 | May 27, 2005 | Substantially Equivalent |
| K050275 | MODIFICATION TO: INION OTPS BIODEGRADABLE PIN | Mar 7, 2005 | Substantially Equivalent |
| K043142 | INION OTPS BIODEGRADABLE MINI PLATING SYSTEM | Feb 18, 2005 | Substantially Equivalent |