FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K Number: K062819
·
Decision Dec 4, 2006
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
50
Applicant Total
23
Review Days
75
Basic Information
- Device Name
- BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
- K Number
- K062819
- 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 20, 2006
- Decision Date
- December 4, 2006
- 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 |
| 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 |
| K022890 | MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Sep 6, 2002 | Substantially Equivalent |