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Alteon

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name
Alteon FDA UDI
Generic Name
Surgical instrument handle, non-torque-limiting FDA UDI
Model / Reference
SPI-046561 FDA UDI

Identifiers

Catalog Number
SPI-046561 FDA UDI
Primary DI / UDI-DI
10885862621887 FDA UDI
510(k) Number
K140674 FDA UDI
K162732 FDA UDI
K182462 FDA UDI
FDA Product Code
KWZ FDA UDI
MEH FDA UDI
GMDN Term
Surgical instrument handle, non-torque-limiting FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3310 FDA UDI
888.3353 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical instrument handle, non-torque-limiting

Alteon by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument handle, non-torque-limiting.

Cleared under the same submission

K140674 also covers:

K162732 also covers:

K182462 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Exactech, Inc.

Sources (1)

  • FDA UDI b53688fc-ce5b-4d58-8b25-8dcd064536d8 34 fields · synced Jun 8, 2026