FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MEDICON IMF-ORION SCREWS
K Number: K050478
·
Decision Jun 15, 2005
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
17
Review Days
111
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Basic Information
- Device Name
- MEDICON IMF-ORION SCREWS
- K Number
- K050478
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medicon EG
- Date Received
- February 24, 2005
- Decision Date
- June 15, 2005
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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|---|---|---|---|
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| K053624 | MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM | Jul 17, 2006 | Substantially Equivalent |
| K043297 | MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM | Feb 23, 2005 | Substantially Equivalent |
| K042974 | MEDICON VIPAIR HIGH SPEED SYSTEM | Jan 13, 2005 | Substantially Equivalent |
| K041527 | AARHUS ANCHORAGE SYSTEM | Aug 19, 2004 | Substantially Equivalent |
| K010910 | MEDICON YASARGIL CLIP APPLYING FORCEPS | Aug 1, 2001 | Substantially Equivalent |
| K010908 | MEDICON TITANIUM YASARGIL ANEURYSM CLIPS | Aug 1, 2001 | Substantially Equivalent |
| K972857 | SERVOTRONIC EC100 SYSTEM | Jan 16, 1998 | Substantially Equivalent |