Bioplate, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Bioplate, Inc.” (first 2000, latest 2008), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 29 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JEY | Plate, Bone | 16 | 16 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 5 | 5 |
| DZL | Screw, Fixation, Intraosseous | 1 | 1 |
| HBC | Motor, Drill, Electric | 1 | 1 |
Review panels
Most recent Bioplate, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082757 | MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM | JEY | 2008-10-01 | 12 |
| K082175 | MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION | GXN | 2008-08-13 | 12 |
| K070901 | MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM | GXN | 2007-06-15 | 74 |
| K062819 | BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | GXN | 2006-12-04 | 75 |
| K051845 | THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM | JEY | 2005-07-27 | 20 |
| K031028 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | 2003-04-28 | 27 |
| K030806 | BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | 2003-04-08 | 26 |
| K023810 | MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | 2002-12-04 | 19 |
| K023665 | MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY | 2002-11-22 | 22 |
| K022986 | THE BIOPLATE BATTERY POWERED DRILL | HBC | 2002-11-19 | 71 |
13 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2010-03-31.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bioplate, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Bioplate, Inc.” (first 2000, latest 2008), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bioplate, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bioplate, Inc. is 29 days.
Which FDA product codes appear under Bioplate, Inc.?
The most frequent FDA product codes under this applicant name are JEY (Plate, Bone, 16); GXN (Plate, Cranioplasty, Preformed, Non-Alterable, 5); DZL (Screw, Fixation, Intraosseous, 1).
Next steps
- See all 23 Bioplate, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JEY, Bioplate, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.