FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE BIOPLATE BATTERY POWERED DRILL
K Number: K022986
·
Decision Nov 19, 2002
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
25
Applicant Total
23
Review Days
71
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- THE BIOPLATE BATTERY POWERED DRILL
- K Number
- K022986
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4360
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioplate, Inc.
- Date Received
- September 9, 2002
- Decision Date
- November 19, 2002
- Product Code
- HBC
- 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 |
|---|---|---|---|
| HBC | Motor, Drill, Electric | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HBC), ordered by most recent decision date.
Traus SSG10 Surgical System
FDA 510(k)
FDA Class 2
·Neurology
Traus SSG30 Surgical System
FDA 510(k)
FDA Class 2
·Neurology
ORiGO System
FDA 510(k)
FDA Class 2
·Neurology
Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
FDA 510(k)
FDA Class 2
·Neurology
hekaDrill
FDA 510(k)
FDA Class 2
·Neurology
MR8 Drill System, Midas Rex MR8 ClearView Tools
FDA 510(k)
FDA Class 2
·Neurology
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 |
| K022890 | MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Sep 6, 2002 | Substantially Equivalent |