FDA.reportPublic FDA data

Impeace Cervical Plate System

Primary DI
00840354203838
Brand
Impeace Cervical Plate System
Company
MEDYNUS, INC.
Model
TP.PL.0242
Catalog number
TP.PL.0242
Device description
2 level Anterior Cervical Plate 42mm
Published
2026-05-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840354203838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840354203838008403542038388403542038380840354203838

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
119458950
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840354203654Impeace Cervical Plate SystemTP.PL.0110TP.PL.01102026-05-06
00840354203661Impeace Cervical Plate SystemTP.PL.0112TP.PL.01122026-05-06
00840354203678Impeace Cervical Plate SystemTP.PL.0114TP.PL.01142026-05-06
00840354203685Impeace Cervical Plate SystemTP.PL.0116TP.PL.01162026-05-06
00840354203692Impeace Cervical Plate SystemTP.PL.0118TP.PL.01182026-05-06
00840354203708Impeace Cervical Plate SystemTP.PL.0120TP.PL.01202026-05-06
00840354203715Impeace Cervical Plate SystemTP.PL.0122TP.PL.01222026-05-06
00840354203722Impeace Cervical Plate SystemTP.PL.0124TP.PL.01242026-05-06
00840354203739Impeace Cervical Plate SystemTP.PL.0126TP.PL.01262026-05-06
00840354203746Impeace Cervical Plate SystemTP.PL.0224TP.PL.02242026-05-06
00840354203753Impeace Cervical Plate SystemTP.PL.0226TP.PL.02262026-05-06
00840354203760Impeace Cervical Plate SystemTP.PL.0228TP.PL.02282026-05-06
00840354203777Impeace Cervical Plate SystemTP.PL.0230TP.PL.02302026-05-06
00840354203784Impeace Cervical Plate SystemTP.PL.0232TP.PL.02322026-05-06
00840354203791Impeace Cervical Plate SystemTP.PL.0234TP.PL.02342026-05-06
00840354203807Impeace Cervical Plate SystemTP.PL.0236TP.PL.02362026-05-06
00840354203814Impeace Cervical Plate SystemTP.PL.0238TP.PL.02382026-05-06
00840354203821Impeace Cervical Plate SystemTP.PL.0240TP.PL.02402026-05-06
00840354203845Impeace Cervical Plate SystemTP.PL.0244TP.PL.02442026-05-06
00840354203852Impeace Cervical Plate SystemTP.PL.0246TP.PL.02462026-05-06

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