Identity
- Trade Name
- Matriform SI-Strip FDA UDI
- Generic Name
- Bone matrix implant, composite FDA UDI
- Device Name
- Device Name: Matriform SI-Strip Indication for Use: Matriform® Si Strip 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 Matriform® Si Strip is to be mixed with autograft bone. The device resorbs and is replaced with bone during the healing process FDA UDI
- Model / Reference
- 50x25x4 mm FDA UDI
- Description
- Device Name: Matriform SI-Strip Indication for Use: Matriform® Si Strip 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 Matriform® Si Strip is to be mixed with autograft bone. The device resorbs and is replaced with bone during the healing process FDA UDI
Identifiers
- Catalog Number
- 1 x 5 cc FDA UDI
- Primary DI / UDI-DI
- ECUR449050 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 SI-Strip by curasan AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone matrix implant, composite.
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- CopiOs® Bone Void Filler Paste — DSM BIOMEDICAL, INC. · Class II
- Vitoss — Stryker Corp. · Class II
- STRATOFUSE Strip — Berkeley Advanced Biomaterials · Class II
- OptiFuse Bi-Ostetic Foam Strip — Berkeley Advanced Biomaterials · Class II
- AlexiFuse Synthetic Foam Strip — Berkeley Advanced Biomaterials · Class II
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- MacroFORM Bioactive Packable Graft 5.0cc — NovaBone Products, LLC · Class II
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 Large — curasan AG
- Matriform Medium — 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 65b510ef-8a67-4898-bc38-722ab4537474 36 fields · synced May 31, 2026