FDA.reportPublic FDA data

Impeace Cervical Plate System

Primary DI
00840354204262
Brand
Impeace Cervical Plate System
Company
MEDYNUS, INC.
Model
TP.VD.4520
Catalog number
TP.VD.4520
Device description
Variable-angle screws (self-drilling), Ø4.5, 20mm
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
00840354204262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840354204262008403542042628403542042620840354204262

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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
00840354203838Impeace Cervical Plate SystemTP.PL.0242TP.PL.02422026-05-06
00840354203845Impeace Cervical Plate SystemTP.PL.0244TP.PL.02442026-05-06

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Primary DI, Brand, Company table
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00810017914623Saber-C Plate, 14x17x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
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00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.KWQ2026-06-05
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