JEY · Class II · 21 CFR 872.4760

FDA Product Code JEY: Plate, Bone

FDA product code JEY covers bone plates used in dental and maxillofacial surgery.

These titanium or resorbable plates are used to stabilize osteotomies and fractures of the mandible, maxilla, and midface. They are fixed with bone screws and provide rigid or semi-rigid fixation during healing of the bony segments.

JEY devices are Class II medical devices, regulated under 21 CFR 872.4760 and reviewed by the FDA Dental panel.

Leading manufacturers include Synthes (Usa), KLS-Martin L.P. and Bioplate, Inc..

294
Total
294
Cleared
134d
Avg days
1984
Since
294 devices
145–168 of 294
Cleared Feb 20, 2002
SYNTHES CRANIAL PLATES
K020087
Synthes (Usa)
Dental · 41d
Cleared Dec 07, 2001
THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K013055
Bioplate, Inc.
Dental · 87d
Cleared Nov 20, 2001
THE BIOPLATE MANDIBLE FIXATION SYSTEM
K012910
Bioplate, Inc.
Dental · 82d
Cleared Oct 05, 2001
INION CPS 2.0 ORTHOGNATHIC PLATE
K013039
Inion , Ltd.
Dental · 25d
Cleared Sep 18, 2001
MACROPORE FX, PS, NS, LP
K012413
Macropore Biosurgery, Inc.
Dental · 50d
Cleared Aug 23, 2001
STRAUMANN GBR SYSTEM
K011698
Institut Straumann AG
Dental · 83d
Cleared Aug 07, 2001
LACTOSORB RAPIDFLAP
K003281
Biomet, Inc.
Dental · 292d
Cleared Jul 11, 2001
MACROPOREPX PEDIATRIC SYSTEM
K002207
Macropore Biosurgery, Inc.
Dental · 355d
Cleared May 14, 2001
MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K011380
Bioplate, Inc.
Dental · 7d
Cleared May 03, 2001
SYNTHES (USA) MIDFACE DISTRACTOR
K010499
Synthes (Usa)
Dental · 71d
Cleared Mar 15, 2001
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM
K010351
Inion , Ltd.
Dental · 37d
Cleared Mar 14, 2001
CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
K010352
Inion , Ltd.
Dental · 36d
Cleared Mar 14, 2001
BIOSORBFX AND BIOSORBPDX MESH
K010687
Bionx Implants, Inc.
Dental · 6d
Cleared Feb 27, 2001
SMF RESORBABLE MESHES AND SHEETS
K003786
Synthes (Usa)
Dental · 81d
Cleared Feb 15, 2001
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS
K003549
Codman & Shurtleff, Inc.
Dental · 90d
Cleared Feb 12, 2001
LORENZ RESORBABLE DISTRACTOR SYSTEM
K002083
Walter Lorenz Surgical, Inc.
Dental · 217d
Cleared Jan 26, 2001
THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY
K002426
Bioplate, Inc.
Dental · 171d
Cleared Jan 24, 2001
THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE
K994060
Bioplate, Inc.
Dental · 421d
Cleared Jan 23, 2001
MOLINA ORBITAL MALAR DISTRACTOR
K003883
KLS-Martin L.P.
Dental · 39d
Cleared Jan 17, 2001
MAXILLARY DISTRACTOR
K003393
Synthes (Usa)
Dental · 77d
Cleared Jan 09, 2001
SYNTHES (USA) RESORBABLE TACK SYSTEM
K000560
Synthes (Usa)
Dental · 326d
Cleared Jan 03, 2001
BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES
K003756
Bionx Implants, Inc.
Dental · 28d
Cleared Dec 12, 2000
LEIBINGER NEURO CLIP SYSTEM
K003660
Stryker Instruments
Dental · 14d
Cleared Dec 06, 2000
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS
K002798
Codman & Shurtleff, Inc.
Dental · 90d