FDA.reportPublic FDA data

Erisma®-LP

Primary DI
03700780630165
Brand
Erisma®-LP
Company
CLARIANCE
Model
13722005
Device description
DOUBLE BREAKING LEVER
Published
2022-04-20
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
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System

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
K162367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162367000Erisma® LP MISClariance, Sas2016-10-27NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700780630165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700780630165037007806301653700780630165

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 773 868 7041s.chambat@clariance-spine.us

Regulatory Flags#

DUNS number
296568400
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
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
00197157122874ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122881ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122898ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122904ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122911ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122928ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122935ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122942ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122959ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122966ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122973ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122980ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122997ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123000ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123017ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123024ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123031ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123048ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123055ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123062ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123079ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123086ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123093ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123109ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123116ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123123ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123130ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123147ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123154ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123161ZAVATION SCREWZavation LLCNKB2026-10-20