Valencia Pedicle Screw System

GUDID B41794265351

6.5mm x 35mm Self Tapping Cannulated Pedicle Screw

Altus Spine, LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDB41794265351
NIH Device Record Key223a951e-be12-4d99-8f7c-e94754ee8244
Commercial Distribution StatusIn Commercial Distribution
Brand NameValencia Pedicle Screw System
Version Model Number942-6535
Company DUNS078331322
Company NameAltus Spine, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com

Device Dimensions

Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100843210112718 [Secondary]
HIBCCB41794265351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

[B41794265351]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-28

On-Brand Devices [Valencia Pedicle Screw System]

00843210134765X connector Module Lid
00843210134758X connector Module Base
008432101347418.5mm Pedicle Tap,Cannulated
008432101347347.5mm Pedicle Tap, Cannulated
008432101347276.5mm Pedicle Tap, Cannulated
008432101347105.5mm Pedicle Tap, Cannulated
00843210134703Cannulated Probe
00843210134697Valencia Auxillary Case Lid-Valencia
00843210134680Rod Module Lid, Valencia II
00843210134673Rod Module, Valencia II
00843210134666Valencia Screw Module Standard Pedicle Screw
00843210134659Auxiliary Case
00843210134642Valencia Sterilization Case 2
00843210134635Valencia Sterilization Case 1
00843210134628T-25 Inserter, Hudson
00843210134611T-25 Drive Shaft, Long
00843210134604Counter Torque, Long
00843210134598MIS Tab Removal, Cannulated
00843210134581Reduction Collar
00843210134574T-25 Tapered Inserter
00843210134567T-25 Removable Tip, Tapered
00843210134550T-25 Final Drive Shaft
00843210134543Rod Pusher
00843210134536Straight Ratcheting Handle
00843210134529Large T-Handle, Ratchet
00843210134512Curved Probe, Duck Bill
00843210134505Straight Probe, Duck Bill
00843210134499Sound Curved
00843210134482Sound
00843210134475Bone Probe Lenke-Style Curve
00843210134468Bone Probe Lenke-Style Strgt
00843210134451PSS: Rod Template
00843210134406Pedicle Marker, Left
00843210134390Pedicle Marker, Right
00843210134383PSS: Counter Torque Instrument
00843210134376PSS: Rod Holder
00843210134369PSS: Screwdriver
00843210134352PARALLEL DISTRACTOR
00843210134345PARALLEL COMPRESSOR
00843210134338PSS: Distractor
00843210134321PSS: Compressor
00843210134277PSS: Rod Bender
00843210134260PSS: T-Handle Ratchet
00843210134222PSS: Awl
00843210133416T-25 Inserter Shaft
00843210133171Sterilization Case Lid
008432101217894.5mm x 25mm Monoaxial Self Tapping Pedicle Screw
00843210121772480mm Guide Wire, Round Tip, Nitinol
00843210121765480mm Guide Wire, Round Tip, Nitinol
008432101217588.5mm x 100mm Cannulated Extension Pedicle Screw
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