FDA.reportPublic FDA data

Integra® MemoFix®

Primary DI
10381780121459
Brand
Integra® MemoFix®
Company
Ascension Orthopedics, Inc.
Model
MS181414
Catalog number
MS181414
Device description
The Integra® MemoFix® staple is a one piece singleuse nickel titanium alloy bone fixation device intendedto be permanently implanted. The device is indicatedfor the fixation of osteotomies and joint arthrodesisof the hands and feet. The implant consists of twolegs connected by a bridge and is offered in multiplecombinations of bridge widths and leg lengths toaccommodate various anatomies.
Published
2017-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K123926000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123926000METASURG NITINOL STAPLE IMPLANTMetasurg2013-05-03JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780121459PrimaryGS10
M268MS1814141SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178012145910381780121459

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
942377524
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780240310Cadence™102031932016-08-24
10381780245513BioMotion® Cannulated 1st MPJ Hemi SystemHM 3010HM 30102017-09-05
10381780245629Titan™IP0920055001IMP-0920-055-0012017-09-05
10381780245636Titan™IP0920064001IMP-0920-064-0012017-09-05
10381780245643Titan™IP0920079501IMP-0920-0795-012017-09-05
10381780245650Titan™IMP096006401IMP-0960-064-012017-09-05
10381780245667Titan™IMP096006601IMP-0960-066-012017-09-05
10381780245674Titan™IMP096007101IMP-0960-071-012017-09-05
10381780245681Ascension®IMP10000DIMP-100-00D2017-09-05
10381780245698Ascension®IMP10000PIMP-100-00P2017-09-05
10381780245704Integra®IMP20000DIMP-200-00D2017-09-05
10381780245711Integra®IMP20000PIMP-200-00P2017-09-05
10381780245728Integra®IMP30000IMP-300-002017-09-05
10381780245735Integra®IMP35000IMP-350-002017-09-05
10381780245759NuGrip® CMC Implant SystemIMP44200IMP-442-002017-09-05
10381780245766First Choice® DRUJ SystemIMP60000IMP-600-002017-09-05
10381780245780Movement®IMP-890-00MTIMP-890-00MT2017-09-05
10381780245797Movement®IMP-890-00PPIMP-890-00PP2017-09-05
10381780245803Integra®IMP90001IMP-900-012017-09-05
10381780245988Integra®MAL092008501MAL-0920-085-012017-08-30

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10886705001033LUPINEDEPUY MITEK, LLCJDR2025-03-04
10886705001040LUPINEDEPUY MITEK, LLCJDR2025-03-04
00810111223683SpeedPlate - SpeedAkinTreace Medical Concepts, Inc.JDR2025-01-27
00810111223485TMC SpeedMTPTreace Medical Concepts, Inc.JDR2024-11-18
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10888867042695Arthrex®ARTHREX, INC.JDR2021-12-03
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