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Signex

FDA UDI

Class II (US FDA UDI)

by OSTEONIC CO., Ltd.

Identity

Trade Name
Signex FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Model / Reference
A5.25070 FDA UDI

Identifiers

Primary DI / UDI-DI
08800071045939 FDA UDI
510(k) Number
K230546 FDA UDI
FDA Product Code
HWC FDA UDI
HRS FDA UDI
GMDN Term
Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone screw (non-sliding)

Signex is a high-quality orthopedic bone screw designed for internal fixation of limb bones, rib, sternum, and pelvis. It features a unique threaded design with a drive at the proximal end, making it suitable for various surgical procedures. Signex has undergone rigorous testing and meet strict industry standards for medical implants.

Similar devices

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

Cleared under the same submission

K230546 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
OSTEONIC CO., Ltd.

Sources (1)

  • FDA UDI 6baf917f-39fa-436b-8be0-5a2eb04fca31 33 fields · synced Jun 25, 2026