FDA.reportPublic FDA data

Bone Impactor

Primary DI
10840199500472
Brand
Bone Impactor
Company
KOROS U.S.A., INC.
Model
7224-20
Catalog number
7224-20
Device description
Bone Impactor 6 x 12mm tip
Published
2022-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840199500475Direct MarkingGS10
10840199500472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199500475008401995004758401995004750840199500475
1084019950047210840199500472

GMDN Terms#

Term, Definition table
TermDefinition
External spinal fixation systemAn assembly of devices designed to stabilize adjacent segments (i.e., vertebrae) of the spine. It typically consists of an external plastic and/or metallic fixator and other external and/or implantable components, such as plates, rods, pins, and bone screws; it may also include some instruments appropriate for attaching the implants (e.g., screw drivers, wrenches, drills). The system is intended for temporary immobilization of segments of the spine in patients with fractures of the thoracic and/or lumbar spine and also for some patients suffering of segmental instability or chronic back pain. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-805-529-0825customerservice@korosUSA.com

Regulatory Flags#

DUNS number
007928633
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
00840199528837Comfort Plus Chisel7540-067540-062025-01-31
00840199507726Separator7230-107230-102024-12-31
00840199507733Separator7230-157230-152024-12-31
00840199507740Elevator7230-187230-182024-12-31
00840199507757Elevator7230-207230-202024-12-31
00840199507764Elevator7230-257230-252024-12-31
00840199507771Elevator7230-307230-302024-12-31
00840199507788Elevator7230-357230-352024-12-31
00840199507795Elevator7230-407230-402024-12-31
00840199507801Elevator7230-427230-422024-12-31
00840199507818Elevator7230-437230-432024-12-31
00840199507870Elevator7230-607230-602024-12-31
00840199507900Hook7232-057232-052024-12-31
00840199507917Hook7232-107232-102024-12-31
00840199507924Hook7232-157232-152024-12-31
00840199507962Elevator7232-287232-282024-12-31
00840199507979Vein Retractor7232-307232-302024-12-31
00840199507986Vein Retractor7232-357232-352024-12-31
00840199507993Vein Retractor7232-407232-402024-12-31
00840199511426Chisel7315-217315-212024-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536216710neon3Ulrich GmbH & Co. KGKWP2026-05-26
00763000817305VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-03-16
00763000817312VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-03-16
03662663086233LineSiderHighridge Medical, LLCKWP2025-10-03
03662663091046LineSiderHighridge Medical, LLCKWP2025-10-03
03662663091084LineSiderHighridge Medical, LLCKWP2025-10-03
03662663091091LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097345LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097352LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097369LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097376LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097383LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097390LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097406LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097413LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097420LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097437LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097444LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097451LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097468LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097475LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097482LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097499LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097505LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097512LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097529LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097536LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097543LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097550LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097567LineSiderHighridge Medical, LLCKWP2025-10-03