FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
INION CPS/OTPS FREEDOMPLATE
K Number: K063410
·
Decision Jan 23, 2007
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
23
Review Days
71
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Basic Information
- Device Name
- INION CPS/OTPS FREEDOMPLATE
- K Number
- K063410
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inion , Ltd.
- Date Received
- November 13, 2006
- Decision Date
- January 23, 2007
- Product Code
- HRS
- 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L
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Other Clearances by Inion , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K071810 | INION SPINAL GRAFT CONTAINMENT SYSTEM | Jul 11, 2008 | Unknown |
| 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 |
| K031714 | INION TRINION BIODEGRADABLE MENISCUS SCREW | Aug 16, 2004 | Substantially Equivalent |