FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
K Number: K020088
·
Decision Feb 8, 2002
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
55
Applicant Total
23
Review Days
29
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
- MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
- K Number
- K020088
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5330
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioplate, Inc.
- Date Received
- January 10, 2002
- Decision Date
- February 8, 2002
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXN), ordered by most recent decision date.
3D MAC Titanium Cranial Plate (TCP) System
FDA 510(k)
FDA Class 2
·Neurology
EASYMADE-TI
FDA 510(k)
FDA Class 2
·Neurology
METICULY Patient-specific titanium mesh implant
FDA 510(k)
FDA Class 2
·Neurology
Synthes Patient Specific Implants
FDA 510(k)
FDA Class 2
·Neurology
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
FDA 510(k)
FDA Class 2
·Neurology
CustomizedBone Service
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 |
| K022986 | THE BIOPLATE BATTERY POWERED DRILL | Nov 19, 2002 | Substantially Equivalent |