FDA.reportPublic FDA data

VICEROY Spinal System

Primary DI
88000163003212
Brand
VICEROY Spinal System
Company
EOS BIOTEK,INC.
Model
V-0200 7545
Published
2016-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122229000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122229000VICEROY SPINAL SYSTEMTorrey Spine2012-11-20NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
88000163003212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8800016300321288000163003212

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1-858-345-5840Brandon@torreyspineusa.com

Regulatory Flags#

DUNS number
689605712
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
88000163001850VICEROY Spinal SystemV-0200 55352016-10-04
88000163001928VICEROY Spinal SystemV-0200 55402016-10-04
88000163002086VICEROY Spinal SystemV-0200 55452016-10-04
88000163002154VICEROY Spinal SystemV-0200 55502016-10-04
88000163002222VICEROY Spinal SystemV-0200 55552016-10-04
88000163002468VICEROY Spinal SystemV-0200 65352016-10-04
88000163002536VICEROY Spinal SystemV-0200 65402016-10-04
88000163002604VICEROY Spinal SystemV-0200 65452016-10-04
88000163002772VICEROY Spinal SystemV-0200 65502016-10-04
88000163002840VICEROY Spinal SystemV-0200 65552016-10-04
88000163002918VICEROY Spinal SystemV-0200 65602016-10-04
88000163003076VICEROY Spinal SystemV-0200 75352016-10-04
88000163003144VICEROY Spinal SystemV-0200 75402016-10-04
88000163003380VICEROY Spinal SystemV-0200 75502016-10-04
88000163003458VICEROY Spinal SystemV-0200 75552016-10-04
88000163005438VICEROY Spinal SystemV-0400 55352016-10-04
88000163005506VICEROY Spinal SystemV-0400 55402016-10-04
88000163005674VICEROY Spinal SystemV-0400 55452016-10-04
88000163005742VICEROY Spinal SystemV-0400 55502016-10-04
88000163006046VICEROY Spinal SystemV-0400 65352016-10-04

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Primary DI, Brand, Company table
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