FDA.report

Valencia Pedicle Screw System

Primary DI
B41796065601
Brand
Valencia Pedicle Screw System
Company
Altus Spine, LLC
Model
960-6560
Device description
6.5mm x 60mm Multi-Axial Pedicle 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

Contact Domains

Product Codes

CodeName
MNHOrthosis, spondylolisthesis spinal fixation

Product Code Classifications

CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B41796065601PrimaryHIBCC0
00843210114095SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00843210114095008432101140958432101140950843210114095

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
Length60Millimeter
Outer Diameter6.5Millimeter

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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00843210161358Indy StandaloneSL38271612T2024-10-04
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00843210169156Indy Standalone1030-42352024-10-04
00843210169163Indy Standalone1030-42402024-10-04
00843210169170Indy Standalone1030-02152024-10-04

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