FDA.reportPublic FDA data

YUKON OCT Spinal System

Primary DI
10888857464070
Brand
YUKON OCT Spinal System
Company
VB Spine LLC
Model
7611-540600-55S
Catalog number
7611-540600-55S
Device description
Transition Rod Size Ø4.0-5.5 mm x600 mm CoCr
Published
2020-12-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193129000Yukon OCT Spinal SystemK2m, Inc.2020-02-07NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857464070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885746407010888857464070

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

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
false
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
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
10888857082588CHESAPEAKE Stabilization System3608-900343608-900342022-06-01
10888857461819CASCADIA™ Interbody System6101-2852209NL6-G26101-2852209NL6-G22019-10-31
10888857461888CASCADIA™ Interbody System6101-2852205NL12-G26101-2852205NL12-G22019-10-31
10888857218772CASCADIA™ Interbody System6101-2225008LP-G26101-2225008LP-G22015-12-16
10888857218963CASCADIA™ Interbody System6101-2224512LP-G26101-2224512LP-G22015-12-16
10888857219076CASCADIA™ Interbody System6101-2225014LP-G26101-2225014LP-G22015-12-16
10888857219489CASCADIA™ Interbody System6101-2225508LL8-G26101-2225508LL8-G22015-12-16
10888857219595CASCADIA™ Interbody System6101-2226010LL8-G26101-2226010LL8-G22015-12-16
10888857252820DENALI® Spinal System1301-900391301-900392026-08-28
10888857615724OZARK Cervical Plate SystemPRO-1445PRO-14452026-09-22
10888857037953EVEREST® Spinal System2901-5601002901-5601002026-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000992521INFINITY OCT SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-09-26
00763000992552INFINITY OCT SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-09-26
00840606186544OMEGA XPSPINAL ELEMENTS, INC.KWP2026-09-22
00840606186551OMEGA XPSPINAL ELEMENTS, INC.KWP2026-09-22
10888857598164Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
00613994738646ZEPHIR® Anterior Cervical SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2019-03-07
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
04546540147257XIA IIStryker CorporationKWP2014-12-08
04546540147769XIA IIStryker CorporationKWP2014-12-08
04546540147806XIA IIStryker CorporationKWP2014-12-08
04546540147905XIA IIStryker CorporationKWP2014-12-08
04546540147912XIA IStryker CorporationKWP2014-12-08
04546540147929XIA IStryker CorporationKWP2014-12-08
04546540147936XIA IStryker CorporationKWP2014-12-08
04546540147974XIA IStryker CorporationKWP2014-12-08
04546540147981XIA IStryker CorporationKWP2014-12-08
04546540147998XIA IStryker CorporationKWP2014-12-08
04546540148001XIA IIStryker CorporationKWP2014-12-08