FDA.reportPublic FDA data

AccuPlan System

Primary DI
00810007632223
Brand
AccuPlan System
Company
Medcad
Model
ZB-KP100
Catalog number
ZB-KP100
Device description
MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE
Published
2023-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZJDriver, Wire, And Bone Drill, Manual
JEYPlate, Bone
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2
JEYPlate, BoneDental2
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810007632223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810007632223008100076322238100076322230810007632223

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbable, non-customizedA small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be included with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(214) 453-8864support@medcad.com

Regulatory Flags#

DUNS number
144723868
Device count
1
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810007633282AccuStride SystemMC-3D132MC-3D1322025-06-30
00810007633299AccuStride SystemMC-3D133MC-3D1332025-06-30
00810007633305AccuStride SystemMC-3D134MC-3D1342025-06-30
00810007633312AccuStride SystemMC-3D131MC-3D1312025-06-30
00810007633244AccuStride SystemMC-KST000MC-KST0002025-06-10
00081000763324AccuStride SystemMC-KST000MC-KST0002025-05-05
00810007633251AccuStride SystemMC-KST000-RMC-KST000-R2025-05-05
00810007633268AccuStride SystemMC-KST001MC-KST0012025-05-05
00810007633442AccuStride System MC-KSP003MC-KSP0032026-02-20
00810007633398AccuStride System MC-STP001MC-STP0012026-02-04
00810007633404AccuStride System MC-STP002MC-STP0022026-02-04
00810007633411AccuStride System MC-KSP000MC-KSP0002026-02-04
00810007633428AccuStride System MC-KSP001MC-KSP0012026-02-04
00810007633435AccuStride System MC-KSP002MC-KSP0022026-02-04
00810007633343AccuPlan SystemMC-3D217MC-3D2172025-10-31
00810007633350AccuPlan SystemMC-3D218MC-3D2182025-10-31
00810007633367AccuPlan SystemZB-3D217ZB-3D2172025-10-31
00810007633374AccuPlan SystemZB-3D218ZB-3D2182025-10-31
00810007633381AccuPlan SystemZB-KFITZB-KFIT2025-10-31
00810007633336AccuPlan System MC-KFITMC-KFIT2025-10-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVDZJ2026-10-20
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TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
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TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
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TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20