Identity
- Trade Name
- VELOCITY ALPHA ™ FDA UDI
- Generic Name
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
- Device Name
- foot control, electric, Bluetooth™ wireless, incl. Bluetooth™ dongle VAFCD and bar for foot switch VMME-FS-H FDA UDI
- Model / Reference
- foot control, electric, Bluetooth™ wireless, incl. Bluetooth™ dongle VAFCD FDA UDI
- Description
- foot control, electric, Bluetooth™ wireless, incl. Bluetooth™ dongle VAFCD and bar for foot switch VMME-FS-H FDA UDI
Identifiers
- Catalog Number
- VAFCBT FDA UDI
- Primary DI / UDI-DI
- 04251388956854 FDA UDI
- 510(k) Number
- K191479 FDA UDI
- FDA Product Code
- HBE FDA UDI
- GMDN Term
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4310 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Velocity Alpha ™ by adeor Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone/joint surgical power tool motorized handpiece/set, electric, reusable.
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
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- SSG10 — Saeshin Precision Co., Ltd. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- ACCULAN 3TI — AESCULAP, INC. · Class I
Cleared under the same submission
K191479 also covers:
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
- VELOCITY ALPHA ™ — adeor Medical AG
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
- adeor Medical AG
Sources (1)
- FDA UDI 78b46628-c323-4c53-af4b-f74d1eddb4c7 35 fields · synced Jun 8, 2026