FDA.reportPublic FDA data

Impeace Cervical Plate System

Primary DI
00840354205009
Brand
Impeace Cervical Plate System
Company
MEDYNUS, INC.
Model
TP.FDA.4510
Catalog number
TP.FDA.4510
Device description
Fixed-angle screws (self-drilling Aggressive), Ø4.5, 10mm
Published
2026-05-07
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
00840354205009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840354205009008403542050098403542050090840354205009

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840354204958Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204965Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204972Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204989Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204996Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205016Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205023Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205030Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205047Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205054Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205061Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205078Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205085Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205092Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205108Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205115Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205122Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205139Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205146Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205153Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205160Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205177Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205184Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205191Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205207Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354203654Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203661Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203678Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203685Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203692Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06