FDA.reportPublic FDA data

Ti Retractor Blade 3

Primary DI
10840199500274
Brand
Ti Retractor Blade 3
Company
KOROS U.S.A., INC.
Model
7233-64
Catalog number
7233-64
Device description
Ti blade Retractors 3 - 14 cmx17 cmx13 mm
Published
2022-10-31
Public version status
New
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
00840199500277Direct MarkingGS10
10840199500274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199500277008401995002778401995002770840199500277
1084019950027410840199500274

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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