FDA.reportPublic FDA data

YUKON OCT Spinal System

Primary DI
10888857590403
Brand
YUKON OCT Spinal System
Company
VB Spine LLC
Model
7601-04536T
Catalog number
7601-04536T
Device description
Polyaxial Screw, ML Dual Lead Ø4.5x36 mm
Published
2025-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
NKGPosterior cervical screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193129000
K242361000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193129000Yukon OCT Spinal SystemK2m, Inc.2020-02-07NKG
K242361000OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MIStryker Spine2024-11-07KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857590403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885759040310888857590403

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length36Millimeter
Outer Diameter4.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(571)919-2000mark.zellers@stryker.com

Regulatory Flags#

DUNS number
119508156
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888857598164Xia® 3 System - Serrato®482614020V482614020V2026-07-24
10888857598171Xia® 3 System - Serrato®482614025V482614025V2026-07-24
10888857598188Xia® 3 System - Serrato®482614030V482614030V2026-07-24
10888857598195Xia® 3 System - Serrato®482614035V482614035V2026-07-24
10888857598201Xia® 3 System - Serrato®482614040V482614040V2026-07-24
10888857598218Xia® 3 System - Serrato®482614045V482614045V2026-07-24
10888857598225Xia® 3 System - Serrato®482614520V482614520V2026-07-24
10888857598232Xia® 3 System - Serrato®482614525V482614525V2026-07-24
10888857598249Xia® 3 System - Serrato®482614530V482614530V2026-07-24
10888857598256Xia® 3 System - Serrato®482614535V482614535V2026-07-24
10888857598263Xia® 3 System - Serrato®482614540V482614540V2026-07-24
10888857598270Xia® 3 System - Serrato®482614545V482614545V2026-07-24
10888857598287Xia® 3 System - Serrato®482615020V482615020V2026-07-24
10888857598294Xia® 3 System - Serrato®482615025V482615025V2026-07-24
10888857598300Xia® 3 System - Serrato®482615030V482615030V2026-07-24
10888857598317Xia® 3 System - Serrato®482615035V482615035V2026-07-24
10888857598324Xia® 3 System - Serrato®482615040V482615040V2026-07-24
10888857598331Xia® 3 System - Serrato®482615045V482615045V2026-07-24
10888857598348Xia® 3 System - Serrato®482615050V482615050V2026-07-24
10888857598355Xia® 3 System - Serrato®482615525V482615525V2026-07-24

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Primary DI, Brand, Company table
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00763000992330INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992347INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992453INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00840606192057Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192064Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192071Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192088Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
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00840606192101Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
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00840606192125Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
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00840606192194Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
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00840606192231Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
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00840606192255Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
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00840606192279Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
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00840606192293Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24