FDA.reportPublic FDA data

Odalys

Primary DI
03700406334880
Brand
Odalys
Company
KISCO INTERNATIONAL
Model
Polyaxial screw Ø6 L40
Catalog number
ODPS55640
Device description
The Odalys is a pedicle screw spinal system.
Published
2015-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152098000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152098000ODALYS Pedicle Screw SystemKisco International2015-09-17MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700406334880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700406334880037004063348803700406334880

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

Regulatory Flags#

DUNS number
393107719
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700406301745OdalysPolyaxial spondylolisthesis screw Ø6 L55ODSS556552015-11-02
03700406301769OdalysPolyaxial spondylolisthesis screw Ø7 L55ODSS557552015-11-02
03700406302612OdalysPolyaxial screw Ø7 L55ODPS557552015-11-02
03700406302629OdalysPolyaxial screw Ø5 L55ODPS555552015-11-02
03700406302636OdalysPolyaxial screw Ø6 L55ODPS556552015-11-02
03700406302643OdalysPolyaxial screw Ø5 L45ODPS555452015-11-02
03700406302650OdalysPolyaxial screw Ø5 L50ODPS555502015-11-02
03700406320678OdalysPolyaxial spondylolisthesis screw Ø5 L55ODSS555552015-11-02
03700406334408OdalysLocking capODLS2015-11-02
03700406334828OdalysPolyaxial screw Ø5 L30ODPS555302015-11-02
03700406334835OdalysPolyaxial screw Ø5 L35ODPS555352015-11-02
03700406334842OdalysPolyaxial screw Ø5 L40ODPS555402015-11-02
03700406334866OdalysPolyaxial screw Ø6 L30ODPS556302015-11-02
03700406334873OdalysPolyaxial screw Ø6 L35ODPS556352015-11-02
03700406334897OdalysPolyaxial screw Ø6 L45ODPS556452015-11-02
03700406334903OdalysPolyaxial screw Ø6 L50ODPS556502015-11-02
03700406334927OdalysPolyaxial screw Ø7 L30ODPS557302015-11-02
03700406334934OdalysPolyaxial screw Ø7 L35ODPS557352015-11-02
03700406334941OdalysPolyaxial screw Ø7 L40ODPS557402015-11-02
03700406334958OdalysPolyaxial screw Ø7 L45ODPS557452015-11-02

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