FDA.reportPublic FDA data

PYXIS 3D Titanium Cage System

Primary DI
08809974806043
Brand
PYXIS 3D Titanium Cage System
Company
GS Medical Co., Ltd.
Model
GS132-3210P
Catalog number
GS132-3210P
Device description
3D Printed OLIF II Trial
Published
2025-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809974806043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809974806043088099748060438809974806043

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82432377393udimail@gsmedi.com

Regulatory Flags#

DUNS number
688385418
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809695601903AnyPlus®GS138-5800GS138-58002026-04-21
08809974806050PYXIS 3D Titanium Cage SystemGS132-3212PGS132-3212P2025-10-14
08809974806074PYXIS 3D Titanium Cage SystemGS132-3214PGS132-3214P2025-10-14
08809974806128PYXIS 3D Titanium Cage SystemGS132-3610PGS132-3610P2025-10-14
08809974806135PYXIS 3D Titanium Cage SystemGS132-3612PGS132-3612P2025-10-14
08809974806159PYXIS 3D Titanium Cage SystemGS132-3614PGS132-3614P2025-10-14
08809974806890PYXIS 3D Titanium Cage SystemGS132-6610PGS132-6610P2025-10-14
08809974806906PYXIS 3D Titanium Cage SystemGS132-6612PGS132-6612P2025-10-14
08809974806920PYXIS 3D Titanium Cage SystemGS132-6614PGS132-6614P2025-10-14
08800322752043AnyPlus®GS136-3500GS136-35002026-01-28
08800322752067QUASAR Standalone ACIF SystemGS136-9661GS136-96612026-01-28
08800322752074QUASAR Standalone ACIF SystemGS136-9662GS136-96622026-01-28
08800322752081QUASAR Standalone ACIF SystemGS136-9668GS136-96682026-01-28
08800322752098AnyPlus®GS136-3311GS136-33112026-01-28
08806162109351AnyPlus®GS136-1410GS136-14102026-01-28
08806162109382AnyPlus®GS136-1800GS136-18002026-01-28
08806162109399AnyPlus®GS136-1801GS136-18012026-01-28
08809695589973PYXIS 3D Titanium Cervical Cage, CloseGS110-0981GS110-09812026-01-28
08809695601859AnyPlus®GS138-5520GS138-55202026-01-28
08800322709818AnyPlus®GS136-0632PGS136-0632P2025-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130207435MSIModern Surgical Instruments LLCLXH2026-07-14
00840606188128Ventana ASPINAL ELEMENTS, INC.LXH2026-07-13
08809695601903AnyPlus®GS Medical Co., Ltd.LXH2026-04-21
08800322742945PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742952PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742969PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742976PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742983PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742990PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743003PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743010PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743027PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743034PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743041PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743058PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743065PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743072PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743089PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743096PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743102PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743119PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743126PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743133PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743140PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743157PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743171PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743188PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743195PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743201PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743218PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18