FDA.report

Valencia Pedicle Screw System

Primary DI
B41792350451
Brand
Valencia Pedicle Screw System
Company
Altus Spine, LLC
Model
923-5045
Device description
5.5mm x 45mm Curved Rod
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

Contact Domains

Product Codes

CodeName
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Product Code Classifications

CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B41792350451PrimaryHIBCC0
00843210111209SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00843210111209008432101112098432101112090843210111209

GMDN Terms

TermDefinition
Orthopaedic instrument surgical connectorA small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). This is a reusable device.

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

Other Devices From This Company

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00843210189505Brickyard Stand-Alone ALIF1030-0101G-452025-09-02
00843210190457Brickyard Stand-Alone ALIF1030-3215G-452025-09-02
00843210190464Brickyard Stand-Alone ALIF1030-3220G-452025-09-02
00843210190471Brickyard Stand-Alone ALIF1030-3225G-452025-09-02
00843210190488Brickyard Stand-Alone ALIF1030-3230G-452025-09-02
00843210190495Brickyard Stand-Alone ALIF1030-3235G-452025-09-02
00843210190501Brickyard Stand-Alone ALIF1030-3240G-452025-09-02
00843210176567Sochi300-09012025-03-13
00843210170749Indy Standalone1030-0301G-452024-10-07
00843210189154Brickyard Stand-Alone ALIF1020-20002024-10-07
00843210189437Brickyard Stand-Alone ALIF1030-0301G-452024-10-07
00843210159492Indy StandaloneSL382716122024-10-04
00843210161358Indy StandaloneSL38271612T2024-10-04
00843210169118Indy Standalone1030-42152024-10-04
00843210169125Indy Standalone1030-42202024-10-04
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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