← Back to catalogue

Signex

FDA UDI

Class I (US FDA UDI)

by OSTEONIC CO., Ltd.

Identity

Trade Name
Signex FDA UDI
Generic Name
Orthopaedic surgical distractor, internal FDA UDI
Model / Reference
Y7Z.00060 FDA UDI

Identifiers

Primary DI / UDI-DI
08800071031864 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic surgical distractor, internal FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

Yes

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 surgical distractor, internal

Signex by OSTEONIC CO., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical distractor, internal.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
OSTEONIC CO., Ltd.

Sources (1)

  • FDA UDI 65f69a90-ea68-4e6f-a9b2-fbf9ba6501f8 32 fields · synced Jun 6, 2026