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PYXIS 3D Titanium X-TLIF Cage, Open

FDA UDI

Class II (US FDA UDI)

by GS Medical Co., Ltd.

Identity

Trade Name
PYXIS 3D Titanium X-TLIF Cage, Open FDA UDI
Generic Name
Metallic spinal interbody fusion cage FDA UDI
Device Name
The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral space after resection of the disc.The PYXIS 3D Titanium Cage devices consist of implants in various heights, footprints, and lordotic configurations with architecture designed to accept pre and post packing of bone graft material. The intervertebral body devices are made of titanium alloy (Ti-6AL-4V ELI).The PYXIS 3D Titanium Cage devices are not radio lucent, but have large windows through the sides that will allow visualization of the placement and subsequent bone fusion. FDA UDI
Model / Reference
8100-4210S FDA UDI
Description
The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral space after resection of the disc.The PYXIS 3D Titanium Cage devices consist of implants in various heights, footprints, and lordotic configurations with architecture designed to accept pre and post packing of bone graft material. The intervertebral body devices are made of titanium alloy (Ti-6AL-4V ELI).The PYXIS 3D Titanium Cage devices are not radio lucent, but have large windows through the sides that will allow visualization of the placement and subsequent bone fusion. FDA UDI

Identifiers

Catalog Number
8100-4210S FDA UDI
Primary DI / UDI-DI
08800322708798 FDA UDI
510(k) Number
K221687 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Metallic spinal interbody fusion cage FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Metallic spinal interbody fusion cage

PYXIS 3D Titanium X-TLIF Cage, Open by GS Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metallic spinal interbody fusion cage.

Cleared under the same submission

K221687 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
GS Medical Co., Ltd.

Sources (1)

  • FDA UDI d6ca3a12-ba9e-4da6-beae-d62b948cb90b 36 fields · synced Jun 8, 2026