Identity
- Trade Name
- AccelStim FDA UDI
- Generic Name
- Bone growth ultrasonic stimulator FDA UDI
- Device Name
- Casting Kit Assembly, Small, Accessory, ACCELSTIM Model 4300 FDA UDI
- Model / Reference
- 654300-9005 FDA UDI
- Description
- Casting Kit Assembly, Small, Accessory, ACCELSTIM Model 4300 FDA UDI
Identifiers
- Catalog Number
- 4300 Casting Kit Small FDA UDI
- Primary DI / UDI-DI
- 18257200158706 FDA UDI
- FDA Product Code
- LOF FDA UDI
- GMDN Term
- Bone growth ultrasonic stimulator FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone growth ultrasonic stimulator
AccelStim by Orthofix US LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone growth ultrasonic stimulator.
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- EXOGEN® Ultrasound Bone Healing System — BIOVENTUS LLC · Class III
- AccelStim — IGEA SPA · Class III
- Accelstim — IGEA SPA · Class III
- EXOGEN® Ultrasound Bone Healing System — BIOVENTUS LLC · Class III
- EXOGEN® Ultrasound Bone Healing System MOU — BIOVENTUS LLC · Class III
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 III | Pending data |
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Manufacturer
- Manufacturer
- Orthofix US LLC
Sources (1)
- FDA UDI 5dc815f6-f445-4847-9bb6-7658390b251f 35 fields · synced May 30, 2026