FDA.reportPublic FDA data

PYRENEES® Cervical Plate System

Primary DI
10888857113183
Brand
PYRENEES® Cervical Plate System
Company
VB Spine LLC
Model
5901-15022D
Catalog number
5901-15022D
Device description
Screw, Self Starting Size Ø5.0 x 22 mm
Published
2017-01-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K150983000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150983000Pyrenees Cervical Plate SystemK2m2015-07-14KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857113183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885711318310888857113183

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
Length22Millimeter
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(703)777-3155mzellers@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
10888857596740NAPA Access System8030-100228030-100222026-07-31
10888857596757NAPA Access System8030-100238030-100232026-07-31
10888857596764NAPA Access System8030-100248030-100242026-07-31
10888857596771NAPA Access System8030-100258030-100252026-07-31
10888857596788NAPA Access System8030-100268030-100262026-07-31
10888857596795NAPA Access System8030-100278030-100272026-07-31
10888857596801NAPA Access System8030-100288030-100282026-07-31
10888857596818NAPA Access System8030-100298030-100292026-07-31
10888857596825NAPA Access System8030-100308030-100302026-07-31
10888857596832NAPA Access System8030-100318030-100312026-07-31
10888857596849NAPA Access System8030-100328030-100322026-07-31
10888857596856NAPA Access System8030-100338030-100332026-07-31
10888857596863NAPA Access System8030-100348030-100342026-07-31
10888857596870NAPA Access System8030-100358030-100352026-07-31
10888857596887NAPA Access System8030-100368030-100362026-07-31
10888857000018NILE™ Alternative Fixation System5416-F03730-SG5416-F03730-SG2015-09-24
10888857000025NILE™ Alternative Fixation System5416-F04730-SG5416-F04730-SG2015-09-24
10888857018587CAYMAN® Plate System1201-160221201-160222015-09-24
10888857018594CAYMAN® Plate System1201-160241201-160242015-09-24
10888857018600CAYMAN® Plate System1201-160261201-160262015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493425559RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425696RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425702RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425719RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425726RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-08-02
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-30
00840493425382RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425399RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425405RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425412RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425429RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425436RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425443RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425450RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425467RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425474RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28