FDA.reportPublic FDA data

PYRENEES® Cervical Plate System

Primary DI
10888857029811
Brand
PYRENEES® Cervical Plate System
Company
VB Spine LLC
Model
201-90023
Catalog number
201-90023
Device description
Variable Drill Guide, Single Barrel Screw Thru, Size Single Barrel Screw Thru
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142212000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142212000Pyrenees Cervical Plate SystemK2m, Inc.2015-05-01KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857029811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885702981110888857029811

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(703)777-3155sgilbert@k2m.com
+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
10888857487048EVEREST® Spinal SystemSP-5002SP-50022020-10-13
10888857158313TERRA NOVA® MI Access System1501-900601501-900602021-01-29
10888857596894OZARK Cervical Plate SystemPRO-1427-01PRO-1427-012026-05-28
10888857596719Xia® 3PRO-1432-01PRO-1432-012026-05-12
10888857596726Xia® 3PRO-1432-02PRO-1432-022026-05-12
10888857596733Xia® 3PRO-1432-03PRO-1432-032026-05-12
10888857219656CASCADIA™ Interbody System6101-2224012LL8-G26101-2224012LL8-G22016-12-30
10888857219793CASCADIA™ Interbody System6101-2226014LL8-G26101-2226014LL8-G22015-12-16
10888857220966CASCADIA™ Interbody System6101-2224510LL12-G26101-2224510LL12-G22016-12-30
10888857221093CASCADIA™ Interbody System6101-2226012LL12-G26101-2226012LL12-G22016-12-30
10888857221871CASCADIA™ Interbody System6101-2225014LL15-G26101-2225014LL15-G22016-12-30
10888857221895CASCADIA™ Interbody System6101-2226014LL15-G26101-2226014LL15-G22016-12-30
10888857346420CANYON™ Retractor Systems6401-901076401-901072020-06-18
10888857035553RAVINE® Lateral Access System2701-900722701-900722022-02-14
10888857596900OZARK Cervical Plate SystemPRO-1427-10PRO-1427-102026-05-01
10888857596917OZARK Cervical Plate SystemPRO-1427-12PRO-1427-122026-05-01
10888857596924OZARK Cervical Plate SystemPRO-1427-14PRO-1427-142026-05-01
10888857596931OZARK Cervical Plate SystemPRO-1427-16PRO-1427-162026-05-01
10888857596948OZARK Cervical Plate SystemPRO-1427-18PRO-1427-182026-05-01
10888857218765CASCADIA™ Interbody System6101-2224508LP-G26101-2224508LP-G22015-12-16

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