FDA.reportPublic FDA data

Life Instruments

Primary DI
M9308308H0
Brand
Life Instruments
Company
Life Instrument Corporation
Model
830-8H
Device description
"Kerrison Handle 8"""
Published
2026-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9308308H0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. 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
00190776422912MillenniumAvalign Technologies, Inc.HTX2026-08-03
00190776422929MillenniumAvalign Technologies, Inc.HTX2026-08-03
B382SD4319D0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD480007LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD480046220Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482030LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482047PH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482058LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482505LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482506LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD4829130Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD4882030Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD488603SLH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
00190776422455MillenniumAvalign Technologies, Inc.HTX2026-07-31
B382SD1450500050Surgical DirectSurgical Direct, Inc.HTX2026-07-31
B382SD914848050Surgical DirectSurgical Direct, Inc.HTX2026-07-28
B382SD914848060Surgical DirectSurgical Direct, Inc.HTX2026-07-28
B382SD9148641090Surgical DirectSurgical Direct, Inc.HTX2026-07-28
B382SD91486410900Surgical DirectSurgical Direct, Inc.HTX2026-07-28
B382SD9148941000Surgical DirectSurgical Direct, Inc.HTX2026-07-28
B382SD9148001020Surgical DirectSurgical Direct, Inc.HTX2026-07-27
00190776405861MillenniumAvalign Technologies, Inc.HTX2026-07-26
00190776405885MillenniumAvalign Technologies, Inc.HTX2026-07-26
00840183532154BR Surgical, LLCBR Surgical, LLCHTX2026-07-22
00840183532161BR Surgical, LLCBR Surgical, LLCHTX2026-07-22
00840183532178BR Surgical, LLCBR Surgical, LLCHTX2026-07-22
04058749058734NAFehling Instruments GmbH & Co. KGHTX2026-07-17
18257200087396ALIF DISC PREP,ALLOQUENT - ALIFOrthofix US LLCHTX2026-07-17
18257200087402ALIF DISC PREP,ALLOQUENT - ALIFOrthofix US LLCHTX2026-07-17
B382SD914341100Surgical DirectSurgical Direct, Inc.HTX2026-07-13