FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
K Number: K010352
·
Decision Mar 14, 2001
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
23
Review Days
36
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Basic Information
- Device Name
- CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
- K Number
- K010352
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inion , Ltd.
- Date Received
- February 6, 2001
- Decision Date
- March 14, 2001
- Product Code
- JEY
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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|---|---|---|---|
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| 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 |