FDA.reportPublic FDA data

Memodyn staples

Primary DI
03615390002687
Brand
Memodyn staples
Company
GROUPE LEPINE
Model
CSU1110
Device description
BIPOD SHAPE MEMORY STAPLE
Published
2019-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDRStaple, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002695000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002695000MEMODYN STAPLETelos Medical Equipment2001-06-13JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03615390002687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615390002687036153900026873615390002687

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple, non-adjustableA non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33472330295l.fiscus@groupe-lepine.com

Regulatory Flags#

DUNS number
282434968
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03615390002670Memodyn staplesCSU10102019-08-24
03615390002694Memodyn staplesCSU12(1315)2019-08-24
03615390002700Memodyn staplesCSU12102019-08-24
03615390002717Memodyn staplesCSU14102019-08-24
03615390002724Memodyn staplesCSU15152019-08-24
03615390002731Memodyn staplesCSU16102019-08-24
03615390002748Memodyn staplesCSU20152019-08-24
03615390002755Memodyn staplesCSU20202019-08-24
03615390002762Memodyn staplesCSU751.2X1.22019-08-24
03615390002779Memodyn staplesCSU882019-08-24
03615390002786Memodyn staplesCSU992019-08-24

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