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Acumed

FDA UDI

Class II (US FDA UDI)

by Acumed Llc

Identity

Trade Name
ACUMED FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
3.5mm X 34.0mm Cann.Extremity Screw FDA UDI
Model / Reference
FA-0340-S FDA UDI
Description
3.5mm X 34.0mm Cann.Extremity Screw FDA UDI

Identifiers

Primary DI / UDI-DI
10806378065866 FDA UDI
510(k) Number
K915613 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Category: Orthopaedic bone screw (non-sliding)

ACUMED is a high-quality, non-slip orthopedic bone screw designed for internal fixation of fractures in the extremities. This cannulated screw features a robust design with a unique threaded profile and advanced drive system, providing precise and secure fixation. ACUMED meets the highest standards of quality and safety, making it an ideal choice for clinicians and patients alike.

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

Cleared under the same submission

K915613 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Acumed Llc

Sources (1)

  • FDA UDI f7f1839d-8d9d-4e42-9368-d5092f9535f2 35 fields · synced Jul 18, 2026