FDA.reportPublic FDA data

Keos Lumbar Instrument

Primary DI
B0842003800010
Brand
Keos Lumbar Instrument
Company
KEOS
Model
Tamp, Straight, Bayoneted
Catalog number
200-38-0001
Published
2023-02-10
Public version status
Update
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
B0842003800010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. 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
B0842004100100Keos Lumbar InstrumentGraft Pusher200-41-00102023-02-10
B084AC1141605070Anterior Cervical IBFD14D x 16W x 05H x 7L, PEEKAC1-141605-072024-02-09
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
B084AC1161808000Anterior Cervical IBFD16D x 18W x 08H x 0L, PEEKAC1-161808-002024-02-09

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B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
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