Identity
- Trade Name
- Osteoamp Flowable Access Cannula FDA UDI
- Generic Name
- Bone grafting cannula FDA UDI
- Device Name
- The Allograft Delivery Device consists of a cannula and push rod made of biocompatible polypropylene. The device is provided sterile and is intended to be used with hydrated allograft to facilitate delivery into bony defects in orthopedic surgical sites. FDA UDI
- Model / Reference
- OFAC-C FDA UDI
- Description
- The Allograft Delivery Device consists of a cannula and push rod made of biocompatible polypropylene. The device is provided sterile and is intended to be used with hydrated allograft to facilitate delivery into bony defects in orthopedic surgical sites. FDA UDI
Identifiers
- Catalog Number
- OFAC-C FDA UDI
- Primary DI / UDI-DI
- 00816986020525 FDA UDI
- 510(k) Number
- K233368 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Bone grafting cannula FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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 grafting cannula
Osteoamp Flowable Access Cannula by Bioventus Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone grafting cannula.
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- Arthrex® — Arthrex, Inc. · Class I
- Vital™ — BIOMET SPINE LLC · Class I
- AccuPort Cannula End Delivery 8 GA x 150mm Drill Length — Zimmer Knee Creations, Inc. · Class I
- One-Shot — Shanghai Kinetic Medical Co., Ltd. · Class I
- Vital™ — BIOMET SPINE LLC · Class I
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
- Bioventus Llc
Sources (1)
- FDA UDI d1009662-473f-44bb-b380-9fc817bb425d 37 fields · synced Jun 1, 2026