FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
FIXIT HEADREST CLAMP SYSTEM
K Number: K083803
·
Decision Mar 10, 2010
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
49
Applicant Total
17
Review Days
443
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Basic Information
- Device Name
- FIXIT HEADREST CLAMP SYSTEM
- K Number
- K083803
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4460
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medicon EG
- Date Received
- December 22, 2008
- Decision Date
- March 10, 2010
- Product Code
- HBL
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | FDA class 2 | Neurology |
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Other Clearances by Medicon EG
| K Number | Device Name | ||
|---|---|---|---|
| K161680 | MEDICON Spinal Spreading Systems | Mar 24, 2017 | Substantially Equivalent |
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| K053624 | MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM | Jul 17, 2006 | Substantially Equivalent |
| K050478 | MEDICON IMF-ORION SCREWS | Jun 15, 2005 | 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 |