Identity
- Trade Name
- SYNTH™ PLUS FDA UDI
- Generic Name
- Balloon kyphoplasty kit FDA UDI
- Model / Reference
- SYNTH-SPU24 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800038059016 FDA UDI
- 510(k) Number
- K182287 FDA UDI
- FDA Product Code
- HRX FDA UDINDN FDA UDIHXG FDA UDI
- GMDN Term
- Balloon kyphoplasty kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 FDA UDI888.3027 FDA UDI888.4540 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
Category: Balloon kyphoplasty kit
Synth™ Plus by Imedicom Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Balloon kyphoplasty kit.
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Cleared under the same submission
K182287 also covers:
- MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD.
- MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD.
- MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD.
- MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD.
- MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD.
- MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD.
- MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD.
- MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD.
- MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD.
- MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD.
- MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD.
- MEDINAUT Plus Kyphoplasty System — IMEDICOM 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
- Imedicom Co., Ltd.
Sources (1)
- FDA UDI e5503e1d-e906-4eae-aa1e-cc8d4b49ee86 33 fields · synced May 30, 2026