FDA.reportPublic FDA data

Xpine Spinal Fixation System

Primary DI
08800089438655
Brand
Xpine Spinal Fixation System
Company
Jeil Medical Corporation
Model
L69-P60A-5555
Published
2024-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243004000Xpine Spinal Fixation SystemJeil Medical Corporation2024-11-08NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800089438655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800089438655088000894386558800089438655

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688811603
Device count
1
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
08800089483440Surgical InstrumentS111-356-42026-06-10
08800089483464Summa Orthopaedics System Surgical InstrumentSO-S111-356-42026-06-10
08800089483433Drill bit111-6062026-06-10
08800089483457Summa Orthopaedics System Surgical InstrumentSO-111-6062026-06-10
08800089479450ARIX System Bone Screw35N-SO-L20-TA2026-06-01
08800089479467ARIX System Bone Screw35N-SO-L22-TA2026-06-01
08800089479474ARIX System Bone Screw35N-SO-L24-TA2026-06-01
08800089479481ARIX System Bone Screw35N-SO-L26-TA2026-06-01
08800089479498ARIX System Bone Screw35N-SO-L28-TA2026-06-01
08800089479504ARIX System Bone Screw35N-SO-L30-TA2026-06-01
08800089479511ARIX System Bone Screw35N-SO-L32-TA2026-06-01
08800089479528ARIX System Bone Screw35N-SO-L34-TA2026-06-01
08800089479535ARIX System Bone Screw35N-SO-L36-TA2026-06-01
08800089479542ARIX System Bone Screw35N-SO-L38-TA2026-06-01
08800089479559ARIX System Bone Screw35N-SO-L40-TA2026-06-01
08800089479566ARIX System Bone Screw35N-SO-L42-TA2026-06-01
08800089479573ARIX System Bone Screw35N-SO-L44-TA2026-06-01
08800089479580ARIX System Bone Screw35N-SO-L46-TA2026-06-01
08800089479597ARIX System Bone Screw35N-SO-L48-TA2026-06-01
08800089479603ARIX System Bone Screw35N-SO-L50-TA2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841732169272PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169289PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169296PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169302PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169319PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
10888857598164Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598256Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598263Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598270Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598287Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598294Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598300Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598317Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598324Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598331Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598348Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598355Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598362Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598379Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598386Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598393Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598409Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24