Cleared Traditional

K001530 - THE BIOPLATE BIOCLIP CRANIOTOMY FIXATIO...

K001530 is an FDA 510(k) clearance for THE BIOPLATE BIOCLIP CRANIOTOMY FIXATIO..., manufactured by Bioplate, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K001530 · Bioplate, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
65d
Days
Class 2
Risk

K001530 is an FDA 510(k) clearance for the THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Bioplate, Inc. (Los Angeles, US). The FDA issued a Cleared decision on July 21, 2000 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bioplate, Inc. devices

FDA 510(k) Submission Details - K001530

510(k) Number K001530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2000
Decision Date July 21, 2000
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 127d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 193
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K001530.
NEWGEN SYSTEM
K002619 · Stryker Instruments · Nov 2000
MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K002879 · Bioplate, Inc. · Oct 2000
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM
K992905 · Codman & Shurtleff, Inc. · Aug 2000
LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
K001238 · Walter Lorenz Surgical, Inc. · May 2000
MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES
K994154 · KLS-Martin L.P. · Feb 2000
MODUS 2.5 MANDIBULAR RECONSTRUCTION SET
K992682 · Medartis AG · Nov 1999