FDA.reportPublic FDA data

Life Instruments

Primary DI
M930701130000
Brand
Life Instruments
Company
Life Instrument Corporation
Model
701-1300-0
Device description
Ball Spike
Published
2022-02-25
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
M930701130000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic ball spikeA hand-held manual surgical instrument used in the surgical wound to reposition a bone fragment during a surgical intervention. It is typically a robust instrument designed with a handle at the proximal end and a long, sturdy, shaft that terminates in a singularly pointed ball head at the distal end. It is typically made of high-grade stainless steel and/or synthetic material and is used by the surgeon to reposition and hold bone fragments. 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
M93071015023S10Life Instruments710-1502-3S-12026-09-21
M93071015024S10Life Instruments710-1502-4S-12026-09-21
M93071715021C900Life Instruments717-1502-1C-902026-09-21
M93071715022C900Life Instruments717-1502-2C-902026-09-21
M93071715031C900Life Instruments717-1503-1C-902026-09-21
M93071715032C900Life Instruments717-1503-2C-902026-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
00840606186223ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03