Identity
- Trade Name
- Tribio® DP Cotton Wedge FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone. FDA UDI
- Model / Reference
- C10 SWC08 FDA UDI
- Description
- Tribio® DP Wedge is a bone void filler consisting of 60% hydroxyapatite (HA) and 40% beta-tri-calcium phosphate (TCP). These materials have been the topic of extensive clinical studies for several decades. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. After implantation, the device resorbs and is later replaced by natural bone. FDA UDI
Identifiers
- Catalog Number
- C10 SWC08 FDA UDI
- Primary DI / UDI-DI
- 00816125023738 FDA UDI
- 510(k) Number
- K042636 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Bone matrix implant, synthetic, non-antimicrobial 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone matrix implant, synthetic, non-antimicrobial
Tribio® DP Cotton Wedge by Berkeley Advanced Biomaterials — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K042636 also covers:
- Tribio® DP Cotton Wedge — Berkeley Advanced Biomaterials
- Tribio® DP Cotton Wedge — Berkeley Advanced Biomaterials
- Tribio® DP Cotton Wedge — Berkeley Advanced Biomaterials
- Tribio® DP Evans Wedge — Berkeley Advanced Biomaterials
- Tribio® DP Evans Wedge — Berkeley Advanced Biomaterials
- Tribio® DP Evans Wedge — Berkeley Advanced Biomaterials
- Tribio® DP Evans Wedge — Berkeley Advanced Biomaterials
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Berkeley Advanced Biomaterials
Sources (1)
- FDA UDI 0d45d6a4-25b0-4b2c-a360-ed5c5f109a55 35 fields · synced May 30, 2026