FDA.reportPublic FDA data

Idys™- ALIF

Primary DI
03700780629978
Brand
Idys™- ALIF
Company
CLARIANCE
Model
24720005
Catalog number
24720005
Device description
SELF-RETAINING WRENCH
Published
2019-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
03700780629978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700780629978037007806299783700780629978

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
296568400
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
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
10889981217204MeridianSeaspine Orthopedics CorporationOVD2022-08-25
10889981230906RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230913RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230920RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230937RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230944RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230951RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230968RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230975RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230982RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230999RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231002RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231019RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231026RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231033RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231248RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231255RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231262RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231279RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981214395MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214401MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214418MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214425MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214432MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214449MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214456MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214463MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214470MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214487MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214616MeridianSeaspine Orthopedics CorporationOVD2020-12-30