Identity
- Trade Name
- AccuPort® Cannula FDA UDI
- Generic Name
- Bone grafting cannula FDA UDI
- Model / Reference
- 308.151 FDA UDI
Identifiers
- Catalog Number
- 308.151 FDA UDI
- Primary DI / UDI-DI
- 00889024205239 FDA UDI
- 510(k) Number
- K190814 FDA UDI
- FDA Product Code
- FMF FDA UDIMQV FDA UDI
- GMDN Term
- Bone grafting cannula FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI888.3045 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
AccuPort® Cannula by Zimmer Knee Creations, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone grafting cannula.
- Arthrex® — Arthrex, Inc. · Class I
- Bongold Bone Graft Material — Beijing Allgens Medical Science & Technology Co., Ltd. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- Vital™ — BIOMET SPINE LLC · Class I
- One-Shot — Shanghai Kinetic Medical Co., Ltd. · Class I
- Vital™ — BIOMET SPINE LLC · Class I
- Precision Cannula — Zimmer, Inc. · Class I
- Bongold Bone Graft Material — Beijing Allgens Medical Science & Technology Co., Ltd. · Class II
Cleared under the same submission
K190814 also covers:
- AccuFill ® PreFill — Etex Corp.
- AccuFill ® PreFill — Etex Corp.
- AccuFill® — Etex Corp.
- AccuFill® — Etex Corp.
- AccuPort Multi Directional Delivery Canula 8 Ga x 200 mm Drill Length — Zimmer Knee Creations, Inc.
- AccuPort® Cannula — Zimmer Knee Creations, Inc.
- AccuPort® Cannula — Zimmer Knee Creations, Inc.
- AccuPort® Cannula — Zimmer Knee Creations, Inc.
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
- Zimmer Knee Creations, Inc.
Sources (1)
- FDA UDI e44357e3-e17b-4a7f-b252-88681e81eb67 35 fields · synced Jun 9, 2026