FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM
K Number: K071138
·
Decision Aug 15, 2007
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
28
Applicant Total
16
Review Days
152
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Basic Information
- Device Name
- CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM
- K Number
- K071138
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5250
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Prosurg, Inc.
- Date Received
- March 16, 2007
- Decision Date
- August 15, 2007
- Product Code
- GXR
- 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 |
|---|---|---|---|
| GXR | Cover, Burr Hole | FDA class 2 | Neurology |
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Other Clearances by Prosurg, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K152511 | Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula | Jul 11, 2016 | Substantially Equivalent |
| K152466 | Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) | May 19, 2016 | Substantially Equivalent |
| K152619 | Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) | Apr 29, 2016 | Substantially Equivalent |
| K120766 | ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) | Sep 11, 2012 | Substantially Equivalent |
| K072528 | ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES | Dec 28, 2007 | Substantially Equivalent |
| K070737 | XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES | Jul 25, 2007 | Substantially Equivalent |
| K070846 | MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM | Jul 2, 2007 | Substantially Equivalent |
| K060326 | LASERTX - DIODE LASER & DELIVERY SYSTEM | Apr 5, 2006 | Substantially Equivalent |
| K050488 | TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES | Apr 1, 2005 | Substantially Equivalent |
| K042780 | NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM | Feb 3, 2005 | Substantially Equivalent |