FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
K Number: K013050
·
Decision Dec 10, 2001
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
55
Applicant Total
23
Review Days
90
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Basic Information
- Device Name
- THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
- K Number
- K013050
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5330
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioplate, Inc.
- Date Received
- September 11, 2001
- Decision Date
- December 10, 2001
- Product Code
- GXN
- 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 |
|---|---|---|---|
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | FDA class 2 | Neurology |
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Other Clearances by Bioplate, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K082757 | MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM | Oct 1, 2008 | Substantially Equivalent |
| K082175 | MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION | Aug 13, 2008 | Substantially Equivalent |
| K070901 | MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM | Jun 15, 2007 | Substantially Equivalent |
| K062819 | BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Dec 4, 2006 | Substantially Equivalent |
| K051845 | THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM | Jul 27, 2005 | Substantially Equivalent |
| K031028 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Apr 28, 2003 | Substantially Equivalent |
| K030806 | BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Apr 8, 2003 | Substantially Equivalent |
| K023810 | MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Dec 4, 2002 | Substantially Equivalent |
| K023665 | MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Nov 22, 2002 | Substantially Equivalent |
| K022986 | THE BIOPLATE BATTERY POWERED DRILL | Nov 19, 2002 | Substantially Equivalent |