Company ยท US
Bioplate, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2008. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 1, 2008 | K082757 | MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM Bioplate, Inc. | JEY |
| Aug 13, 2008 | K082175 | MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION Bioplate, Inc. | GXN |
| Jun 15, 2007 | K070901 | MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. | GXN |
| Dec 4, 2006 | K062819 | BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. | GXN |
| Jul 27, 2005 | K051845 | THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM Bioplate, Inc. | JEY |
| Apr 28, 2003 | K031028 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. | JEY |
| Apr 8, 2003 | K030806 | BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. | JEY |
| Dec 4, 2002 | K023810 | MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. | JEY |
| Nov 22, 2002 | K023665 | MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. | JEY |
| Nov 19, 2002 | K022986 | THE BIOPLATE BATTERY POWERED DRILL Bioplate, Inc. | HBC |
| Sep 6, 2002 | K022890 | MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. | JEY |
| Jul 19, 2002 | K022033 | STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM Bioplate, Inc. | JEY |
| Jun 26, 2002 | K021684 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. | JEY |
| Feb 8, 2002 | K020088 | MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. | GXN |
| Dec 10, 2001 | K013050 | THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. | GXN |
| Dec 7, 2001 | K013055 | THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. | JEY |
| Nov 28, 2001 | K012908 | BIOPLATE RESORBABLE BONE SCREW Bioplate, Inc. | DZL |
| Nov 20, 2001 | K012910 | THE BIOPLATE MANDIBLE FIXATION SYSTEM Bioplate, Inc. | JEY |
| May 14, 2001 | K011380 | MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. | JEY |
| Jan 26, 2001 | K002426 | THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY Bioplate, Inc. | JEY |
| Jan 24, 2001 | K994060 | THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE Bioplate, Inc. | JEY |
| Oct 5, 2000 | K002879 | MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. | JEY |
| Jul 21, 2000 | K001530 | THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. | JEY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2011 | Bioplate Inc Bioplate Titanium Fixation System, Sterile Kit.
The sterile plate and screw kit configurations for use with the Bioplate Titanium Fixation System are intended for use on non-load bearing fixation, in Terminated |
JEY | K082757 |
| Oct 19, 2006 | Bioplate Inc Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45 Terminated |
JEY | K051845 |