FDA.reportPublic FDA data

Keos Lumbar Instrument

Primary DI
B0842004300010
Brand
Keos Lumbar Instrument
Company
KEOS
Model
Pituitary Rongeur, 4x10mm, Up, w/ Teeth
Catalog number
200-43-0001
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
B0842004300010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. 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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