FDA.reportPublic FDA data

Keos Lumbar Instrument

Primary DI
B0842004700050
Brand
Keos Lumbar Instrument
Company
KEOS
Model
Box Chisel, 11H
Catalog number
200-47-0005
Published
2023-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0842004700050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080551837
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B0842003800000Keos Lumbar InstrumentTamp, Straight200-38-00002023-02-10
B0842003800010Keos Lumbar InstrumentTamp, Straight, Bayoneted200-38-00012023-02-10
B0842004100100Keos Lumbar InstrumentGraft Pusher200-41-00102023-02-10
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B084AC1141606070Anterior Cervical IBFD14D x 16W x 06H x 7L, PEEKAC1-141606-072024-02-09
B084AC1141607070Anterior Cervical IBFD14D x 16W x 07H x 7L, PEEKAC1-141607-072024-02-09
B084AC1141608070Anterior Cervical IBFD14D x 16W x 08H x 7L, PEEKAC1-141608-072024-02-09
B084AC1141609070Anterior Cervical IBFD14D x 16W x 09H x 7L, PEEKAC1-141609-072024-02-09
B084AC1141610070Anterior Cervical IBFD14D x 16W x 10H x 7L, PEEKAC1-141610-072024-02-09
B084AC1141611070Anterior Cervical IBFD14D x 16W x 11H x 7L, PEEKAC1-141611-072024-02-09
B084AC1141612070Anterior Cervical IBFD14D x 16W x 12H x 7L, PEEKAC1-141612-072024-02-09
B084AC1161805000Anterior Cervical IBFD16D x 18W x 05H x 0L, PEEKAC1-161805-002024-02-09
B084AC1161805040Anterior Cervical IBFD16D x 18W x 05H x 4L, PEEKAC1-161805-042024-02-09
B084AC1161805070Anterior Cervical IBFD16D x 18W x 05H x 7L, PEEKAC1-161805-072024-02-09
B084AC1161806000Anterior Cervical IBFD16D x 18W x 06H x 0L, PEEKAC1-161806-002024-02-09
B084AC1161806040Anterior Cervical IBFD16D x 18W x 06H x 4L, PEEKAC1-161806-042024-02-09
B084AC1161806070Anterior Cervical IBFD16D x 18W x 06H x 7L, PEEKAC1-161806-072024-02-09
B084AC1161807000Anterior Cervical IBFD16D x 18W x 07H x 0L, PEEKAC1-161807-002024-02-09
B084AC1161807040Anterior Cervical IBFD16D x 18W x 07H x 4L, PEEKAC1-161807-042024-02-09
B084AC1161807070Anterior Cervical IBFD16D x 18W x 07H x 7L, PEEKAC1-161807-072024-02-09

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