Identity
- Trade Name
- BKP-10-12.0-15.0 FDA UDI
- Generic Name
- Balloon kyphoplasty kit FDA UDI
- Model / Reference
- G10015 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815212026669 FDA UDI
- 510(k) Number
- K200763 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
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
MR Unsafe FDA UDI
Category: Balloon kyphoplasty kit
Bkp-10-12.0-15.0 by Izi Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Balloon kyphoplasty kit.
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- InflateFX™ Gen II Fracture Management — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- KMC Double Balloon Assembly, 8 Gauge, 20mm — Shanghai Kinetic Medical Co., Ltd. · Class II
- Zavation — ZAVATION · Class II
- SYNTH™ PLUS — IMEDICOM CO., LTD. · Class II
Cleared under the same submission
K200763 also covers:
- BKP-10-12.0-15.0-A — IZI MEDICAL PRODUCTS LLC
- BKP-10-12.0-15.0-B — IZI MEDICAL PRODUCTS LLC
- BKP-11-12.0-15.0 — IZI MEDICAL PRODUCTS LLC
- BKP-11-12.0-15.0-A — IZI MEDICAL PRODUCTS LLC
- BKP-11-12.0-15.0-B — IZI MEDICAL PRODUCTS LLC
- Osteo-site Verbebral Augmentation Introducer 10G — IZI MEDICAL PRODUCTS LLC
- Osteo-site Vertebral Augmentation Introducer 11G — IZI MEDICAL PRODUCTS LLC
- OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G — IZI MEDICAL PRODUCTS LLC
- OsteoPearl Vertebral Balloon (15mm), 10G — IZI MEDICAL PRODUCTS LLC
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
- Izi Medical Products Llc
Sources (1)
- FDA UDI 4b7cd2d6-4bf1-4022-9461-ee64bdfbe37f 33 fields · synced May 30, 2026