Bioplate® P2XW-07-17[US]
GUDID M384P2XW0717US0
X Plate - Ø1.5 mm - 7 hole - 17 mm
Bioplate, Inc
Craniofacial fixation plate, non-bioabsorbable| Primary Device ID | M384P2XW0717US0 |
| NIH Device Record Key | dd8930ce-0602-4ad6-a95a-da93ecb8954d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bioplate® |
| Version Model Number | P2XW-07-17[US] |
| Catalog Number | P2XW-07-17[US] |
| Company DUNS | 838734093 |
| Company Name | Bioplate, Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com | |
| Phone | 888-246-7528 |
| INFO@bioplate.com |
Device Dimensions
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
| Length | 17 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M384P2XW0717US0 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K002426
FDA Product Code
| JEY | Plate, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
[M384P2XW0717US0]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-02-05 |
| Device Publish Date | 2016-11-08 |
On-Brand Devices [Bioplate®]
| M384817462CP0 | Short Screwdriver Blade - Cross Drive - Handle (B) |
| M3848174620 | Short Screwdriver Blade - Cross Drive - Handle (B) |
| M384813159CP0 | BioMesh® 2ME - 69 x 79 mm |
| M384P2ST16630 | Straight Plate - Ø1.5 mm - 16 hole - 63 mm |
| M384P2MC1200 | BioMesh® 2MC - 120 mm Round |
| M384ADG501SALE0 | DEPTH GAUGE |
| M384ABP430SALE0 | Plate Bender- Ø2.0 mm - 3 Prong |
| M384ABP230SALE0 | Plate Bender- Ø1.5 mm - 3 Prong |
| M384ABC2110 | PLATE CUTTER - MEDIUM |
| M3848120811 | Self-Drilling Screw - Ø1.5 mm x 5 mm [50 PK] |
| M384AFS210SALE0 | Forceps - Straight |
| M384AFA2200 | Forceps - Angled |
| M3848135640 | Forceps - Straight |
| M3848134920 | FORCEPS ANGLED, PLATE HOLDING |
| M3848134910 | FORCEPS ANGLED, PLATE HOLDING |
| M384812024CP0 | Forceps - Angled |
| M3848120240 | Forceps - Angled |
| M384CRSH50SALE0 | Sterilization Container - MaxFax® |
| M384CRSH500 | Sterilization Container - MaxFax® |
| M384CRSH120 | Sterilization Container - Orbital |
| M384CPS850SALE0 | Plate & Screw Container - MaxFax® - Ø1.2 mm |
| M384CPS8500 | Plate & Screw Container - MaxFax® - Ø1.2 mm |
| M384CPS450SALE0 | Plate & Screw Container - MaxFax® - Ø2.0 mm |
| M384CPS4500 | Plate & Screw Container - MaxFax® - Ø2.0 mm |
| M384CPS250SALE0 | Plate & Screw Container - MaxFax® - Ø1.5 mm |
| M384CPS2500 | Plate & Screw Container - MaxFax® - Ø1.5 mm |
| M384CPS2120 | Plate & Screw Container - Orbital |
| M384CAS2010 | OFFICE KIT CONTAINER - 1.5 MM |
| M384814209CP0 | Biomesh® Container - 1.9 mm |
| M3848142090 | Biomesh® Container - 1.9 mm |
| M384814208CP0 | Biomesh® Container - 1.5 mm |
| M3848142080 | Biomesh® Container - 1.5 mm |
| M3848142060 | 1.9 mm Plate & Screw Container |
| M384814205CP0 | 1.5 mm Plate & Screw Container |
| M3848142050 | 1.5 mm Plate & Screw Container |
| M3848135670 | CUSTOM MODULE INSERT - NEURO |
| M3848135650 | Zip® Container |
| M3848133630 | Xpress® Container |
| M3848131260 | Compact 1.9mm diam. Container |
| M3848131220 | Compact 1.5mm diam. Container |
| M3848131190 | Extended Sterilization Container |
| M3848131090 | 1.9mm diam. Plate & Screw Container |
| M3848131050 | 1.5mm diam. Plate & Screw Container |
| M3848130470 | Plate & Screw Container 1.9 mm |
| M3848120260 | Sterilization Container Neurosurgery |
| M3848120250 | Plate & Screw Container 1.5 mm |
| M384P8YP0617US0 | Y Plate - Ø1.2 mm - 6 hole - 17 mm |
| M384P8YP06170 | Y Plate - Ø1.2 mm - 6 hole - 17 mm |
| M384P8XP0716US0 | X Plate - Ø1.2 mm - 7 hole - 16 mm |
| M384P8XP07160 | X Plate - Ø1.2 mm - 7 hole - 16 mm |
Trademark Results [Bioplate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOPLATE 90748938 not registered Live/Pending |
MS Sedco, Inc. 2021-06-02 |
 BIOPLATE 90748900 not registered Live/Pending |
MS Sedco, Inc. 2021-06-02 |
 BIOPLATE 75842504 not registered Dead/Abandoned |
BIOPLATE, INC. 1999-11-08 |
 BIOPLATE 75589872 2328592 Live/Registered |
BIOCORP, INC. 1998-11-16 |
 BIOPLATE 75291285 2161944 Live/Registered |
BIOPLATE, INC. 1997-05-13 |
 BIOPLATE 74704829 1988470 Dead/Cancelled |
Sudrabin, David A. 1995-07-24 |
 BIOPLATE 74662170 not registered Dead/Abandoned |
BIOMEDIC, INC. 1995-04-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.