FDA.reportPublic FDA data

PYXIS 3D Titanium Cervical Cage System

Primary DI
08800322742976
Brand
PYXIS 3D Titanium Cervical Cage System
Company
GS Medical Co., Ltd.
Model
GS166-7015P
Catalog number
GS166-7015P
Device description
3D Cervical Cage Trial
Published
2025-12-18
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
08800322742976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800322742976088003227429768800322742976

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
08800322708224Anyplus ll Spinal Fixation SystemGS120-2340GS120-23402026-04-21
08800322727270Anyplus ll Spinal Fixation SystemGS120-5500GS120-55002025-10-14
08800322727287Anyplus ll Spinal Fixation SystemGS120-5501GS120-55012025-10-14
08800322727294Anyplus ll Spinal Fixation SystemGS120-5502GS120-55022025-10-14
08800322727300Anyplus ll Spinal Fixation SystemGS120-5503GS120-55032025-10-14
08800322727317Anyplus ll Spinal Fixation SystemGS120-5504GS120-55042025-10-14
08800322727324Anyplus ll Spinal Fixation SystemGS120-5505GS120-55052025-10-14
08800322727331Anyplus ll Spinal Fixation SystemGS120-5506GS120-55062025-10-14
08800322727348Anyplus ll Spinal Fixation SystemGS120-5507GS120-55072025-10-14
08800322727355Anyplus ll Spinal Fixation SystemGS120-5508GS120-55082025-10-14
08800322750001AnyPlus®GS120-1150GS120-11502026-04-21
08800322758120PYXIS 3D Titanium Cervical Cage, CloseGS166-9020GS166-90202026-04-21
08800322758137Anyplus ll Spinal Fixation SystemGS120-8200GS120-82002026-04-21
08800322758144Anyplus ll Spinal Fixation SystemGS120-8210GS120-82102026-04-21
08800322758151Anyplus ll Spinal Fixation SystemGS120-8300GS120-83002026-04-21
08800322758168Anyplus ll Spinal Fixation SystemGS120-8310GS120-83102026-04-21
08800322758175Anyplus ll Spinal Fixation SystemGS120-8900GS120-89002026-04-21
08800322758182Anyplus ll Spinal Fixation SystemGS120-8540GS120-85402026-04-21
08800322758199Anyplus ll Spinal Fixation SystemGS120-8545GS120-85452026-04-21
08800322758205Anyplus ll Spinal Fixation SystemGS120-8550GS120-85502026-04-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606188128Ventana ASPINAL ELEMENTS, INC.LXH2026-07-13
B382SD9141791400Surgical DirectSurgical Direct, Inc.LXH2026-07-13
B382SD9142211000Surgical DirectSurgical Direct, Inc.LXH2026-07-13
00199150075034Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-10
07640177820907Neo Medical Pedicle screw kitNeo Medical SALXH2026-07-10
00840286860093Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00190446924838Arsenal FootTrilliant Surgical, LLCLXH2026-06-24
00190446948469Arsenal FootTrilliant Surgical, LLCLXH2026-06-24
00190446948476Arsenal FootTrilliant Surgical, LLCLXH2026-06-24
00840067212189TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212196TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212202TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212219TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212226TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212233TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212240TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212257TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212264TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212271TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212288TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212295TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212301TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212318TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00889929072752NEXXT MATRIXX® Stand Alone ALIF SystemNEXXT SPINE, LLCLXH2026-06-24
00889929072769NEXXT MATRIXX® Stand Alone ALIF SystemNEXXT SPINE, LLCLXH2026-06-24
00889929072776NEXXT MATRIXX® Stand Alone ALIF SystemNEXXT SPINE, LLCLXH2026-06-24
00889929072783NEXXT MATRIXX® Stand Alone ALIF SystemNEXXT SPINE, LLCLXH2026-06-24
04046826486631Stern-a-Fix Sternal Closure SystemMedicon eG. Chirurgiemechaniker-GenossenschaftLXH2026-06-24