FDA.reportPublic FDA data

Life Instruments

Primary DI
M9307921206B0
Brand
Life Instruments
Company
Life Instrument Corporation
Model
792-1206-B
Device description
Cup Positioner 28mm Ball
Published
2022-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
M9307921206B0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical distractor, externalA hand-operated surgical instrument designed to noninvasively distract (force apart) a joint to facilitate an orthopaedic surgical procedure (e.g., hip arthroscopy). It is a mechanical tool with a manual trigger, for distraction and release, intended to be stabilized against a fixation point adjacent to the target joint (e.g., between the knee and the thigh for knee distraction, or between the joint and a patient positioner attached to the operating table). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
948025002
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M93072110120F0Life Instruments 721-1012-0F2026-05-18
M9306440000T0Life Instruments644-0000-T2026-05-11
M930702110900Life Instruments702-1109-02026-05-11
M930702120820Life Instruments 702-1208-22026-05-11
M930702122800Life Instruments702-1228-02026-05-11
M930702140800Life Instruments702-1408-02026-05-11
M930702200500Life Instruments 702-2005-02026-05-11
M930702200520Life Instruments702-2005-22026-05-11
M930702232000Life Instruments 702-2320-02026-05-11
M930702831500Life Instruments702-8315-02026-05-11
M930706002000Life Instruments702-0020-02026-05-11
M9307251015020Life Instruments725-1015-0-22026-05-11
M9307850001T0Life Instruments 785-0001-T2026-05-11
M9307860000T0Life Instruments786-0000-T2026-05-11
M930703001000Life Instruments703-0010-02022-02-04
M930703100500Life Instruments703-1005-02022-02-04
M9307411230030Life Instruments741-1230-0-32026-03-23
M93071015043S20Life Instruments 710-1504-3S-22026-03-23
M93071015044S20Life Instruments710-1504-4S-22026-03-23
M93074301120SB0Life Instruments743-0112-0SB2026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130207435MSIModern Surgical Instruments LLCLXH2026-07-14
00840606188128Ventana ASPINAL ELEMENTS, INC.LXH2026-07-13
08809695601903AnyPlus®GS Medical Co., Ltd.LXH2026-04-21
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08800322743201PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743218PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18