Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Hard/soft-tissue ultrasonic surgical system FDA UDI
- Device Name
- Osteotomy, osteoplasty, decorticating, drilling, shaping and smoothing of the bones and teeth in various surgical procedures, including but not limited to general, orthopedic, otolaryngologic, maxillofacial, oral, hand/foot, neurosurgery, spinal, and plastic/reconstructive surgery. FDA UDI
- Model / Reference
- TIP BS1L M+ STERILE FDA UDI
- Description
- Osteotomy, osteoplasty, decorticating, drilling, shaping and smoothing of the bones and teeth in various surgical procedures, including but not limited to general, orthopedic, otolaryngologic, maxillofacial, oral, hand/foot, neurosurgery, spinal, and plastic/reconstructive surgery. FDA UDI
Identifiers
- Catalog Number
- F87982 FDA UDI
- Primary DI / UDI-DI
- 03609820879826 FDA UDI
- 510(k) Number
- K163610 FDA UDI
- FDA Product Code
- JDX FDA UDI
- GMDN Term
- Hard/soft-tissue ultrasonic surgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.4580 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: Hard/soft-tissue ultrasonic surgical system
Acteon by Satelec — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hard/soft-tissue ultrasonic surgical system.
- OSCAR 3 — Orthofix, Inc. · Class II
- TORS — RADLEY SCIENTIFIC LIMITED · Class II
- OSCAR 3 — Orthofix, Inc. · Class II
- Axiom Blades — Peter Brasseler Holdings, LLC · Class II
- Piezomed Pro Accessory — W & H Dentalwerk Bürmoos GmbH · Class II
- OSCAR 3 — Orthofix, Inc. · Class II
- OSCAR 3 — Orthofix, Inc. · Class II
- TORS — RADLEY SCIENTIFIC LIMITED · Class II
Cleared under the same submission
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
- Satelec
Sources (1)
- FDA UDI b3e4fb97-bc44-4afe-8c4a-49d17708a141 36 fields · synced May 30, 2026