Identity
- Trade Name
- Bone Biopsy Device FDA UDI
- Generic Name
- Bone grafting cannula FDA UDI
- Device Name
- Bone Biopsy Device, 9G (3.5mm) FDA UDI
- Model / Reference
- FG2511 FDA UDI
- Description
- Bone Biopsy Device, 9G (3.5mm) FDA UDI
Identifiers
- Catalog Number
- FG2511 FDA UDI
- Primary DI / UDI-DI
- 06938695537690 FDA UDI
- 510(k) Number
- K113742 FDA UDI
- FDA Product Code
- NDN FDA UDIHRX FDA UDI
- GMDN Term
- Bone grafting cannula FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 FDA UDI888.1100 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.5 Millimeter FDA UDI
Category: Bone grafting cannula
Bone Biopsy Device by Shanghai Kinetic Medical Co., Ltd. — 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
- AccuPort® Cannula — Zimmer Knee Creations, Inc. · Class II
- 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
- Vital™ — BIOMET SPINE LLC · Class I
- Precision Cannula — Zimmer, Inc. · Class I
Cleared under the same submission
K113742 also covers:
- Access Needle — Shanghai Kinetic Medical Co., Ltd.
- Balloon Catheter — Shanghai Kinetic Medical Co., Ltd.
- Balloon Catheter — Shanghai Kinetic Medical Co., Ltd.
- Balloon Catheter — Shanghai Kinetic Medical Co., Ltd.
- Balloon Catheter Curved — Shanghai Kinetic Medical Co., Ltd.
- Balloon Catheter Syringe Pump — Shanghai Kinetic Medical Co., Ltd.
- Bone Filler Device — Shanghai Kinetic Medical Co., Ltd.
- Bone Filler Device — Shanghai Kinetic Medical Co., Ltd.
- Cannula — Shanghai Kinetic Medical Co., Ltd.
- Drill — Shanghai Kinetic Medical Co., Ltd.
- KMC Access Needle, 11 Gauge, 115mm, Pyramid Tip — Shanghai Kinetic Medical Co., Ltd.
- KMC Access Needle, 11 Gauge, 95mm, Pyramid Tip — Shanghai Kinetic Medical Co., Ltd.
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
- Shanghai Kinetic Medical Co., Ltd.
Sources (1)
- FDA UDI 565d00b8-8bb3-4ab7-9c72-3bc8cfe8b4b7 38 fields · synced May 30, 2026