Identity
- Trade Name
- Matriform Large FDA UDI
- Generic Name
- Bone matrix implant, composite FDA UDI
- Device Name
- Device Name: Matriform Large Mofidication: Mouldable Foam Indication for Use: Matriform Large 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 Large resorbs and is replaced with bone during healing process. FDA UDI
- Model / Reference
- 25x50x4 mm FDA UDI
- Description
- Device Name: Matriform Large Mofidication: Mouldable Foam Indication for Use: Matriform Large 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 Large resorbs and is replaced with bone during healing process. FDA UDI
Identifiers
- Catalog Number
- 1 x 5 cc FDA UDI
- Primary DI / UDI-DI
- ECUR409050 FDA UDI
- 510(k) Number
- K160566 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Bone matrix implant, composite FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone matrix implant, composite
Matriform Large by curasan AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K160566 also covers:
- CERASORB® Ortho Foam — curasan AG
- CERASORB® Ortho Foam — curasan AG
- CERASORB® Ortho Foam — curasan AG
- CERASORB® Ortho Foam — curasan AG
- CERASORB® Ortho Foam — curasan AG
- CERASORB® Ortho Foam — curasan AG
- CERASORB® Ortho Foam — curasan AG
- Matriform Extra Large — curasan AG
- Matriform Medium — curasan AG
- Matriform SI-Strip — curasan AG
- Matriform SI-Strip — curasan AG
- Matriform Smal — curasan AG
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- curasan AG
Sources (1)
- FDA UDI c5105d06-9e1e-4083-ae46-658c2c0bcf02 36 fields · synced Jun 6, 2026