Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Bioplate, Inc. · Predicate Candidate Screening

23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

29 daysmedian FDA review time

90 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K082757	MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WI	Bioplate, Inc.	2008-10-01	12	1
K082175	MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIO	Bioplate, Inc.	2008-08-13	12	0
K070901	MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION S	Bioplate, Inc.	2007-06-15	74	0
K062819	BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL S	Bioplate, Inc.	2006-12-04	75	0
K051845	THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM	Bioplate, Inc.	2005-07-27	20	1
K031028	THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMA	Bioplate, Inc.	2003-04-28	27	0
K030806	BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILL	Bioplate, Inc.	2003-04-08	26	0
K023810	MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM	Bioplate, Inc.	2002-12-04	19	0
K023665	MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANI	Bioplate, Inc.	2002-11-22	22	0
K022986	THE BIOPLATE BATTERY POWERED DRILL	Bioplate, Inc.	2002-11-19	71	0
K022890	MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXAT	Bioplate, Inc.	2002-09-06	7	0
K022033	STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BI	Bioplate, Inc.	2002-07-19	28	0
K021684	THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMA	Bioplate, Inc.	2002-06-26	35	0
K020088	MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM	Bioplate, Inc.	2002-02-08	29	0
K013050	THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM	Bioplate, Inc.	2001-12-10	90	0
K013055	THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM	Bioplate, Inc.	2001-12-07	87	0
K012908	BIOPLATE RESORBABLE BONE SCREW	Bioplate, Inc.	2001-11-28	90	0
K012910	THE BIOPLATE MANDIBLE FIXATION SYSTEM	Bioplate, Inc.	2001-11-20	82	0
K011380	MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYS	Bioplate, Inc.	2001-05-14	7	0
K002426	THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAX	Bioplate, Inc.	2001-01-26	171	0
K994060	THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILL	Bioplate, Inc.	2001-01-24	421	0
K002879	MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM	Bioplate, Inc.	2000-10-05	20	0
K001530	THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM	Bioplate, Inc.	2000-07-21	65	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda