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Maxima™ ACP System

FDA UDI

Class I (US FDA UDI)

by CG MedTech Co., Ltd.

Identity

Trade Name
Maxima™ ACP System FDA UDI
Generic Name
Intraoperative bone pin/screw, non-sterile FDA UDI
Model / Reference
SCS1005 FDA UDI

Identifiers

Primary DI / UDI-DI
08800015957724 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Intraoperative bone pin/screw, non-sterile 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Intraoperative bone pin/screw, non-sterile

Maxima™ ACP System by CG MedTech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraoperative bone pin/screw, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CG MedTech Co., Ltd.

Sources (1)

  • FDA UDI 39d8d1f1-8f50-425a-ba79-c8375d05b4e4 33 fields · synced May 30, 2026