FDA.reportPublic FDA data

CERACELL Ortho Foam

Primary DI
ECURCCLM2525
Brand
CERACELL Ortho Foam
Company
curasan AG
Model
25x25x4 mm
Catalog number
1 x 2.5 cc
Device description
Device Name: CERACELL® Ortho Foam Indication for Use: CERACELL® Ortho Foam is intended to fill bony voids or gaps of the skeletal system (posterolateral spine). These osseous defects may be surgically created or from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the posterolateral spine CERACELL® Ortho Foam is to be mixed with autograft bone. The device resorbs and is replaced with bone during the healing process.
Published
2026-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K181721000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181721000Ceracell Ortho FoamCurasan AG2018-09-17MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ECURCCLM2525PrimaryHIBCC0

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.

Contacts#

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

Regulatory Flags#

DUNS number
324331826
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ECUR9000301001CERASORB M Ortho1000-2000µm1 x 1.0 cc2026-06-25
ECUR9000305001CERASORB M Ortho1000-2000µm1 x 5.0 cc2026-06-25
ECUR9000310001CERASORB M Ortho1000-2000µm1 x 10.0 cc2026-06-25
ECUR9000405001CERASORB M Ortho2000-3000µm1 x 5.0 cc2026-06-25
ECUR9000410001CERASORB M Ortho2000-3000µm1 x 10.0 cc2026-06-25
ECUR9000430001CERASORB M Ortho2000-3000µm3 x 10.0 cc2026-06-25
ECUR9000510001CERASORB M Ortho3000-5000µm1 x 10.0 cc2026-06-25
ECUR9000530001CERASORB M Ortho3000-5000µm3 x 10.0 cc2026-06-25
ECUR9000630001CERASORB M Ortho5000-8000µm3 x 10.0 cc2026-06-25
ECUR9380000057CERASORB Bioactive0.25-1mm5x0.5cc2026-06-25
ECUR9380000058CERASORB Bioactive1-2mm5x1.0cc2026-06-25
ECUR9920302VerteFrame25x25x4 mm1 x 2.5 cc2026-06-25
ECUR9920305VerteFrame25x50x4 mm1 x 5.0 cc2026-06-25
ECUR9920310VerteFrame25x100x4mm1 x 10.0 cc2026-06-25
ECURCCLF25100CERACELL Ortho Foam25x100x4 mm1 x 10.0 cc2026-06-25
ECURCCLF25250CERACELL Ortho Foam65x65x6 mm1 x 25.0 cc2026-06-25
ECURCCLF2550CERACELL Ortho Foam25x50x4 mm1 x 5.0 cc2026-06-25
ECURCCLM25100CERACELL Ortho Foam25x100x4 mm1 x 10.0 cc2026-06-25
ECURCCLM2512CERACELL Ortho Foam25x12x4 mm1 x 1.2 cc2026-06-25
ECURCCLM2550CERACELL Ortho Foam25x50x4 mm1 x 5.0 cc2026-06-25

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Primary DI, Brand, Company table
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ECURCCLF25250CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
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