Acteon

FDA UDI

Class II (US FDA UDI)

by Satelec

Identity

Trade Name: ACTEON FDA UDI
Generic Name: Hard/soft-tissue ultrasonic surgical system FDA UDI
Device Name: Long, ultra-sharp saw (15mm), slim profile, equipped with four sharpened teeth, intended for facilitating ramus grafts. Alternative DI : 10887587009698 FDA UDI
Model / Reference: 03.000.402S FDA UDI
Description: Long, ultra-sharp saw (15mm), slim profile, equipped with four sharpened teeth, intended for facilitating ramus grafts. Alternative DI : 10887587009698 FDA UDI

Identifiers

Catalog Number: F87709 FDA UDI
Primary DI / UDI-DI: 03609820877099 FDA UDI
510(k) Number: K100410 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

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

K100410 also covers:

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 49860fcc-b549-4e8c-9a90-01bd0bf215d8 36 fields · synced Jun 8, 2026