FDA.report

Valencia Pedicle Screw System

Primary DI
B41799055451
Brand
Valencia Pedicle Screw System
Company
Altus Spine, LLC
Model
990-5545
Device description
5.5mm x 45mm Dual Lead Closed Head Screw
Published
2016-10-28
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
true

Related Records

Product Codes

CodeName
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications

CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B41799055451PrimaryHIBCC0
00843210116914SecondaryGS10

GMDN Terms

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

TypeValueUnit
Length45Millimeter
Outer Diameter5.5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(610)355-4156Info@altus-spine.com

Regulatory Flags

DUNS number
078331322
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00843210190464Brickyard Stand-Alone ALIF1030-3220G-452025-09-02
00843210190471Brickyard Stand-Alone ALIF1030-3225G-452025-09-02
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00843210159492Indy StandaloneSL382716122024-10-04
00843210161358Indy StandaloneSL38271612T2024-10-04
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00843210169132Indy Standalone1030-42252024-10-04
00843210169149Indy Standalone1030-42302024-10-04
00843210169156Indy Standalone1030-42352024-10-04
00843210169163Indy Standalone1030-42402024-10-04
00843210169170Indy Standalone1030-02152024-10-04

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