Matriform Strip

Primary DI
ECUR429050
Brand
Matriform Strip
Company
curasan AG
Model
25x50x4 mm
Catalog number
1 x 5 cc
Device description
Device Name: Matriform StripMofidication: Flexible FoamIndication for Use:Matriform Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Matriform Strip resorbs and is replaced with bone during healing process.
Published
2018-03-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160566000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160566000Cerasorb Ortho FoamCurasan AG2016-12-02MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ECUR429050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, compositeA sterile bioabsorbable device made of synthetic bone substitute materials (e.g., ceramics such as tricalcium phosphate or hydroxyapatite) combined with bone growth factors (e.g., bovine collagen) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+496027409000info@curasan.de

Regulatory Flags#

DUNS number
324331826
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ECUR449050Matriform SI-Strip50x25x4 mm1 x 5 cc2020-02-20
ECUR449100Matriform SI-Strip100x25x4mm1 x 10 cc2020-02-20
04260476431005IngeniOS ß-TCP Bioactiv Synthetic Bone Particles0.25-1mm 1x0.25cc2019-10-30
04260476431012IngeniOS ß-TCP Bioactiv Synthetic Bone Particles0.25-1mm 1x0.5cc2019-10-30
04260476431029IngeniOS ß-TCP Bioactiv Synthetic Bone Particles0.25-1mm 1x1cc2019-10-30
04260476431036IngeniOS ß-TCP Bioactiv Synthetic Bone Particles0.25-1mm 1x2cc2019-10-30
04260476431104IngeniOS ß-TCP Bioactiv Synthetic Bone Particles1-2mm 1x0.5cc2019-10-30
04260476431111IngeniOS ß-TCP Bioactiv Synthetic Bone Particles1-2mm 1x1cc2019-10-30
04260476431128IngeniOS ß-TCP Bioactiv Synthetic Bone Particles1-2mm 1x2cc2019-10-30
04260476431203IngeniOS HA0.25-1mm 1x0.25cc2019-10-30
04260476431210IngeniOS HA0.25-1mm 1x0.5cc2019-10-30
04260476431227IngeniOS HA0.25-1mm 1x1cc2019-10-30
04260476431234IngeniOS HA0.25-1mm 1x2cc2019-10-30
04260476431302IngeniOS HA1-2mm 1x0.5cc2019-10-30
04260476431319IngeniOS HA1-2mm 1x1cc2019-10-30
04260476431326IngeniOS HA1-2mm 1x2cc2019-10-30
42604764310052IngeniOS ß-TCP Bioactiv Synthetic Bone Particles0.25-1mm 1x0.25cc2017-10-24
42604764310120IngeniOS ß-TCP Bioactiv Synthetic Bone Particles0.25-1mm 1x0.5cc2017-10-24
42604764310298IngeniOS ß-TCP Bioactiv Synthetic Bone Particles0.25-1mm 1x1cc2017-10-24
42604764310366IngeniOS ß-TCP Bioactiv Synthetic Bone Particles0.25-1mm 1x2cc2017-10-24

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