FDA.reportPublic FDA data

Dissector Perforator

Primary DI
10840199500168
Brand
Dissector Perforator
Company
KOROS U.S.A., INC.
Model
7222-30
Device description
Dissector Perforator with 13mm tip
Published
2022-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K875290000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K875290000LUMBAR IMPACTION SETT. Korossurgical Instruments Corp.1988-03-04KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840199500161Direct MarkingGS10
10840199500168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199500161008401995001618401995001610840199500161
1084019950016810840199500168

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.

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
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840199515995Fiberoptic Dual End Cable7332-607332-602024-12-31
10840199516008Fiberoptic Light Port7332-627332-622024-12-31
10840199516015Fiberoptic Light Port7332-647332-642024-12-31
10840199531056Impactor7585-027585-022022-03-01
10840199531186Impactor7585-447585-442022-03-01
10840199528834Comfort Plus Chisel7540-067540-062025-01-31
00840199528837Comfort Plus Chisel7540-067540-062025-01-31
10840199500007Dilator Tube Set, Single Use, Sterile 7332-99D7332-99D2022-01-31
10840199507723Separator7230-107230-102024-12-31
10840199507730Separator7230-157230-152024-12-31
10840199507747Elevator7230-187230-182024-12-31
10840199507754Elevator7230-207230-202024-12-31
10840199507761Elevator7230-257230-252024-12-31
10840199507778Elevator7230-307230-302024-12-31
10840199507785Elevator7230-357230-352024-12-31
10840199507792Elevator7230-407230-402024-12-31
10840199507808Elevator7230-427230-422024-12-31
10840199507815Elevator7230-437230-432024-12-31
10840199507877Elevator7230-607230-602024-12-31
10840199507907Hook7232-057232-052024-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982239862CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239886CREOGLOBUS MEDICAL, INC.KWP2026-08-14
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00193982239947CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239961CREOGLOBUS MEDICAL, INC.KWP2026-08-14
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00193982240363CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982240622CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450151CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450168CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450175CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450182CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450199CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521134QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521141QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521158QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521165QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521172QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521189QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521196QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521202QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521219QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521226QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521233QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521240QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521257QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521264QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521271QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982669638CREOGLOBUS MEDICAL, INC.KWP2026-08-14