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KMC OneShot Single Balloon Assembly, 10 Gauge, 10mm
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- KMC OneShot Single Balloon Assembly, 10 Gauge, 10mm FDA UDI
- Generic Name
- Balloon kyphoplasty kit FDA UDI
- Device Name
- KMC OneShot Single Balloon Assembly, 10 Gauge, 10mm FDA UDI
- Model / Reference
- KMCA-301-10 FDA UDI
- Description
- KMC OneShot Single Balloon Assembly, 10 Gauge, 10mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06938695546630 FDA UDI
- 510(k) Number
- K113742 FDA UDI
- FDA Product Code
- NDN FDA UDIHRX FDA UDI
- GMDN Term
- Balloon kyphoplasty kit 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
Yes
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
- Balloon Length — 10 Millimeter FDA UDINeedle Gauge — 10 Gauge FDA UDI
Category: Balloon kyphoplasty kit
KMC OneShot Single Balloon Assembly, 10 Gauge, 10mm by Shanghai Kinetic Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Balloon kyphoplasty kit.
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- Zavation — ZAVATION · Class II
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- Zavation — ZAVATION · Class II
- SYNTH™ PLUS — IMEDICOM CO., LTD. · Class II
- Zavation — ZAVATION · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai Kinetic Medical Co., Ltd.
Sources (1)
- FDA UDI 25dd2876-7ff2-406e-8f0a-98facb28f73f 37 fields · synced May 30, 2026