FDA.reportPublic FDA data

Keos Lumbar Instrument

Primary DI
B0842002300030
Brand
Keos Lumbar Instrument
Company
KEOS
Model
Rotating Distractor, QC, 9mm
Catalog number
200-23-0003
Published
2023-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
B0842002300030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080551837
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
B0842000200000Keos Lumbar Case/CaddyImplant Case, Lumbar IBFD System, w/ Lid200-02-00002023-01-30
B0842000200100Keos Lumbar Case/CaddyInstrument Case, Lumbar IBFD System, w/ Lid200-02-00102023-01-30
B0842000200210Keos Lumbar Case/CaddyLid, Lumbar IBFD System200-02-00212023-01-30
B0842000201000Keos Lumbar Case/CaddyCaddy Assy, 23L x 8W, Straight, PEEK200-02-01002023-01-30
B0842000201010Keos Lumbar Case/CaddyCaddy Assy, 23L x 10W, Straight, PEEK200-02-01012023-01-30
B0842000201020Keos Lumbar Case/CaddyCaddy Assy, 28L x 10W, Straight, PEEK200-02-01022023-01-30
B0842000201030Keos Lumbar Case/CaddyCaddy Assy, 28L x 10W, Curved, PEEK200-02-01032023-01-30
B0842000201040Keos Lumbar Case/CaddyCaddy Assy, 23L x 8W, Straight, PEEK HA-Enhanced200-02-01042023-01-30
B0842000201050Keos Lumbar Case/CaddyCaddy Assy, 23L x 10W, Straight, PEEK HA-Enhanced200-02-01052023-01-30
B0842000201060Keos Lumbar Case/CaddyCaddy Assy, 28L x 10W, Straight, PEEK HA-Enhanced200-02-01062023-01-30
B0842000201070Keos Lumbar Case/CaddyCaddy Assy, 28L x 10W, Curved, PEEK HA-Enhanced200-02-01072023-01-30
B0842000201510Keos Lumbar Case/CaddyCaddy Lid, PEEK200-02-01512023-01-30
B0842000201530Keos Lumbar Case/CaddyCaddy Lid, PEEK HA-Enhanced200-02-01532023-01-30
B0842000202000Keos Lumbar Case/CaddyInstrument Case, Limited Release MPE, w/ Lid200-02-02002023-01-30
B0842000203000Keos Lumbar Case/CaddyAuxiliary Case, w/ Lid200-02-03002023-01-30
B0842002400000Keos Lumbar InstrumentT-Handle, QC, 1/4" Square Adapter200-24-00002023-01-30
B0842002600000Keos Lumbar InstrumentInsertion Handle, Threaded200-26-00002023-01-30
B0842002600100Keos Lumbar InstrumentInsertion Rod, Threaded200-26-00102023-01-30
B0842002700000Keos Lumbar InstrumentInsertion Handle, Clamp200-27-00002023-01-30
B0842002700020Keos Lumbar InstrumentAttachment Knob, Insertion Handle, Clamp200-27-00022023-01-30

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Primary DI, Brand, Company table
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00810161900022EARP INITIAL INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
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00810161900046RETRACTABLE OSTEOTOMERETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900053EARP BLADE 100RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900060EARP BLADE 110RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900077EARP BLADE 120RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900084EARP BLADE 130RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900091EARP BLADE 140RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900107EARP BLADE 150RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900114EARP BLADE 160RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900121EARP BLADE 170RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900138EARP BLADE 180RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900145EARP BLADE 190RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
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00810161900169EARP RETRACTOR CONNECTORRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900176EARP RETRACTOR TILT REPLACEMENTRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900183EARP CUFF TRIAL 3&4MMRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900190EARP CUFF TRIAL 5&6MMRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900206EARP, TRIAL 14X25X08 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900213EARP, TRIAL 14X35X08 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900220EARP, TRIAL 14X35X10 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900237EARP, TRIAL 18X35X8 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900244EARP, TRIAL 18X35X10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900251EARP, TRIAL 18X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900268EARP, TRIAL 18X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900275EARP, TRIAL 18X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900282EARP, TRIAL 18X35X12 14°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
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00810161900343EARP DISC SPACER, 8MMRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15