FDA.report

Valencia Pedicle Screw System

Primary DI
B41792350801
Brand
Valencia Pedicle Screw System
Company
Altus Spine, LLC
Model
923-5080
Device description
5.5mm x 80mm 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
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Product Code Classifications

CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B41792350801PrimaryHIBCC0
00843210111193SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00843210111193008432101111938432101111930843210111193

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
Length80Millimeter
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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00843210169132Indy Standalone1030-42252024-10-04
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00843210169156Indy Standalone1030-42352024-10-04
00843210169163Indy Standalone1030-42402024-10-04
00843210169170Indy Standalone1030-02152024-10-04

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