FDA.reportPublic FDA data

YUKON OCT Spinal System

Primary DI
10888857560437
Brand
YUKON OCT Spinal System
Company
VB Spine LLC
Model
PRO-1314
Catalog number
PRO-1314
Device description
Threaded Rod Reducer
Published
2022-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
10888857560437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885756043710888857560437

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic rod reducerA heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888857615694CHESAPEAKE® Stabilization SystemPRO-1436-02PRO-1436-022026-09-23
10888857615724OZARK Cervical Plate SystemPRO-1445PRO-14452026-09-22
10888857613805Xia® 3PRO-1438PRO-14382026-06-11
10888857613812K2M General InstrumentsPRO-1439PRO-14392026-06-12
10888857599710YUKON OCT Spinal SystemPRO-1435PRO-14352026-08-25
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
10888857598362Xia® 3 System - Serrato®482615530V482615530V2026-07-24
10888857598379Xia® 3 System - Serrato®482615535V482615535V2026-07-24
10888857598386Xia® 3 System - Serrato®482615540V482615540V2026-07-24
10888857598393Xia® 3 System - Serrato®482615545V482615545V2026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078396389TruTORQ Offset T-Handle Sterile, Single UseEca Medical InstrumentsLXH2026-10-20
10810128464144Tendon Stripper, ClosedT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10810128464151Tendon Stripper, OpenT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10810128464168Tunnel Depth ProbeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10840642149838Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
10840642149845Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
B504OMBMAS90006S0BrasselerProvisionLXH2026-10-20
B504OMBMAS90007S0BrasselerProvisionLXH2026-10-20
B504OMBMAS90008S0BrasselerProvisionLXH2026-10-20
B504OMBMLS900040BrasselerProvisionLXH2026-10-20
B504OMBR2544001110BrasselerProvisionLXH2026-10-20
B504OMBR9505023020BrasselerProvisionLXH2026-10-20
B504OMBR9505023030BrasselerProvisionLXH2026-10-20
B504OMDP86011710BrasselerProvisionLXH2026-10-20
B504OMST60070031000BrasselerProvisionLXH2026-10-20
B504OMST60070031500BrasselerProvisionLXH2026-10-20
B504OMST60071031100BrasselerProvisionLXH2026-10-20
B504OMST60071041500BrasselerProvisionLXH2026-10-20
B504OMZB005901020000BrasselerProvisionLXH2026-10-20
00824846013082Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-19
00850078396440SYNQ Single-Use Instrument System(1066)Eca Medical InstrumentsLXH2026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)Zimmer, Inc.LXH2026-10-19
08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
00810161900305EARP, TRIAL 22X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900312EARP, TRIAL 22X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900336EARP, TRIAL 22X35X14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901418EARP TRIAL 22x40x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901425EARP TRIAL 22x40x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16