FDA.reportPublic FDA data

Erisma-LP MIS

Primary DI
03700780634576
Brand
Erisma-LP MIS
Company
CLARIANCE
Model
15780003
Device description
Long Handle for Kobe Persuader
Published
2022-03-15
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
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

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

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
03700780634576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700780634576037007806345763700780634576

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
+17738687041s.chambat@clariance-spine.com

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
M719GL3110TiLockGenesys Orthopedics Systems LLCMNI2026-08-03
M719GLC403S0TiLockGenesys Orthopedics Systems LLCMNI2026-08-03
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-08-02
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-07-30
00841732168527TAURUS Pedicle Screw SystemCTL Medical CorporationMNI2026-07-28
00841732169272PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169289PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169296PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169302PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
00841732169319PICASSO MIS Spinal SystemCTL Medical CorporationMNI2026-07-24
07290115932508Tower Guide STPREMIA SPINE LTDMNI2026-07-23
M719GL2290TiLockGenesys Orthopedics Systems LLCMNI2026-07-14
04047844129418DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129425DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129432DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129449DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129456DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
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04047844129470DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129487DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129494DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129500DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129517DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129524DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129531DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129548DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129555DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129562DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129579DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129586DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13