FDA.reportPublic FDA data

4CIS® INSTRUMENT SYSTEM

Primary DI
08806373546075
Brand
4CIS® INSTRUMENT SYSTEM
Company
ALPHA AI CO.,LTD.
Model
5901-0032
Catalog number
5901-0032
Device description
Bone Curette Angled Left
Published
2019-03-05
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
08806373546075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806373546075088063735460758806373546075

GMDN Terms#

Term, Definition table
TermDefinition
External spinal fixation systemAn assembly of devices designed to stabilize adjacent segments (i.e., vertebrae) of the spine. It typically consists of an external plastic and/or metallic fixator and other external and/or implantable components, such as plates, rods, pins, and bone screws; it may also include some instruments appropriate for attaching the implants (e.g., screw drivers, wrenches, drills). The system is intended for temporary immobilization of segments of the spine in patients with fractures of the thoracic and/or lumbar spine and also for some patients suffering of segmental instability or chronic back pain. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
687844241
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
08800377762103Spinal Fusion Cage SystemDPUC-40J8DPUC-40J82024-02-22
08800377762127Spinal Fusion Cage SystemDPUC-40JADPUC-40JA2024-02-22
08800377762141Spinal Fusion Cage SystemDPUC-40JCDPUC-40JC2024-02-22
08800377762165Spinal Fusion Cage SystemDPUC-40JEDPUC-40JE2024-02-22
08800377762363Spinal Fusion Cage SystemDPUC-45J8DPUC-45J82024-02-22
08800377762387Spinal Fusion Cage SystemDPUC-45JADPUC-45JA2024-02-22
08800377762400Spinal Fusion Cage SystemDPUC-45JCDPUC-45JC2024-02-22
08800377762424Spinal Fusion Cage SystemDPUC-45JEDPUC-45JE2024-02-22
08800377762622Spinal Fusion Cage SystemDPUC-50J8DPUC-50J82024-02-22
08800377762646Spinal Fusion Cage SystemDPUC-50JADPUC-50JA2024-02-22
08800377762660Spinal Fusion Cage SystemDPUC-50JCDPUC-50JC2024-02-22
08800377762684Spinal Fusion Cage SystemDPUC-50JEDPUC-50JE2024-02-22
08800377762882Spinal Fusion Cage SystemDPUC-55J8DPUC-55J82024-02-22
08800377762905Spinal Fusion Cage SystemDPUC-55JADPUC-55JA2024-02-22
08800377762929Spinal Fusion Cage SystemDPUC-55JCDPUC-55JC2024-02-22
08800377762943Spinal Fusion Cage SystemDPUC-55JEDPUC-55JE2024-02-22
08800313887983SOLCO 4CIS® General Plate System96-5081096-508102026-04-21
088003138870444CIS® Spinal System and 4CIS® Low Back System62-4504562-450452026-04-15
088003138870514CIS® Spinal System and 4CIS® Low Back System62-5505062-550502026-04-15
088003138870684CIS® Spinal System and 4CIS® Low Back System62-6503062-650302026-04-15

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Primary DI, Brand, Company table
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00888867620643Arthrex®ARTHREX, INC.LXH2026-10-01
M7401001380OptiLIF Endo, Direct Visualization SystemSPINEOLOGY INC.LXH2026-10-01
00840606191425PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191432PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191449PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191456PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00810017915668SABER-XA, Trial InserterELEVATION SPINE, INC.LXH2026-09-29
00810017916030SABER-XA Straight Awl, Self-GuidedELEVATION SPINE, INC.LXH2026-09-29
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00810055525317Onyx 5.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
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00810055525331Onyx 7.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
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00810055525416Onyx 8.25mm TrephineSi-Bone Inc.LXH2026-09-29
00810055525423Onyx Threaded Removal DriverSi-Bone Inc.LXH2026-09-29
00810055525430Onyx 5.5 & 6.5mm OsteotomeSi-Bone Inc.LXH2026-09-29
00810055525447Onyx 7.5mm OsteotomeSi-Bone Inc.LXH2026-09-29
00810055525454Onyx Counter Torque, ShortSi-Bone Inc.LXH2026-09-29
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00810055525478Onyx Counter Torque, LongSi-Bone Inc.LXH2026-09-29
00810055525485Onyx Head TurnerSi-Bone Inc.LXH2026-09-29