FDA.reportPublic FDA data

n.a.

Primary DI
04048551343425
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
28729KLT
Device description
Knee Laxity Tester
Published
2019-02-23
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
04048551343425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551343425040485513434254048551343425

GMDN Terms#

Term, Definition table
TermDefinition
Joint laxity analyser, battery-poweredA battery-powered device used to measure the functioning of normal or abnormal joints (e.g., a knee) in order to evaluate the slackness and/or displacement in the motion of the joint (i.e., the joint laxity), usually by measuring ranges of motion, acceleration, or forces exerted upon the joint. It may be employed in the assessment of other characteristics of the joint, e.g., stability and/or anterior/posterior tibial displacement. This device is typically used for reconstructive surgery to evaluate and control joint laxity and stability of the knee and the length of the reconstructed ligaments.

Regulatory Flags#

DUNS number
315731430
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551161005n.a.408001102018-09-04
04048551291030NAV1408100202018-08-23
04048551325971n.a.408000212016-09-23
04048551160992n.a.408000902016-09-23
04048551277577n.a.408120202018-08-21
04048551325988n.a.408000512016-09-23
04048551336854NAV1408200202018-08-23
04048551337707n.a.408200862018-08-17
04048551337820NAV1408200302018-08-23
04048551271087n.a.408001202016-09-23
04048551387344n.a.408201232019-02-23
04048551387368n.a.408201502017-03-17
04048551001141n.a.495NCS2016-09-23
04048551004401n.a.495TIP2016-09-23
04048551004463n.a.50200FFL2018-08-21
04048551028568n.a.495ADM2016-09-23
04048551049549n.a.10970AE2018-08-17
04048551049563n.a.10970BE2018-08-17
04048551052495n.a.12016EM2016-09-23
04048551052525n.a.12016FM2016-09-23

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00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
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00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
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00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
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