FDA.reportPublic FDA data

Idys™- ALIF

Primary DI
03700780627134
Brand
Idys™- ALIF
Company
CLARIANCE
Model
24430016-S
Catalog number
24430016-S
Device description
ALIF PLATE
Published
2017-12-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172083000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172083000Idys™ ALIF SystemClariance, Sas2017-11-08OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700780627134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700780627134037007806271343700780627134

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height16Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7738687041s.chambat@clariance-spine.us

Regulatory Flags#

DUNS number
296568400
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700780640195Idys®-ALIF ZP 3DTi45721000457210002026-07-28
03700780654611Idys®-ALIF ZP 3DTi45710003457100032026-07-28
03700780634583Erisma®-LP18710039187100392026-05-28
03700780643554Erisma®-LP15742006157420062026-02-26
03700780600120Idys™- LIF04522008-S04522008-S2015-10-22
03700780600137Idys™- LIF04522009-S04522009-S2015-10-22
03700780600168Idys™- LIF04522012-S04522012-S2015-10-22
03700780600175Idys™- LIF04522013-S04522013-S2015-10-22
03700780600182Idys™- LIF04522508-S04522508-S2015-10-22
03700780600199Idys™- LIF04522509-S04522509-S2015-10-22
03700780600212Idys™- LIF04522011-S04522011-S2015-10-22
03700780600229Idys™- LIF04522512-S04522512-S2015-10-22
03700780600243Idys™- LIF04522514-S04522514-S2015-10-22
03700780600267Idys™- LIF04522809-S04522809-S2015-10-22
03700780600274Idys™- LIF04522810-S04522810-S2015-10-22
03700780600281Idys™- LIF04522811-S04522811-S2015-10-22
03700780600298Idys™- LIF04522812-S04522812-S2015-10-22
03700780600311Idys™- LIF04522814-S04522814-S2015-10-23
03700780600335Idys™- LIF04523209-S04523209-S2015-10-23
03700780600342Idys™- LIF04523210-S04523210-S2015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.OVD2026-10-01
10888857160460CASCADIA™ Interbody SystemVB Spine LLCOVD2018-04-16
10888857223769CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223776CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223783CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217584CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217591CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217669CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19