FDA.reportPublic FDA data

PYXIS 3D Titanium Cervical Cage, Close

Primary DI
08809885739751
Brand
PYXIS 3D Titanium Cervical Cage, Close
Company
GS Medical Co., Ltd.
Model
GS166-1900
Catalog number
GS166-1900
Device description
3D Cervical Cage Impactor
Published
2026-01-28
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
HWAImpactor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809885739751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809885739751088098857397518809885739751

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). 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
08800104097980Anyplus II Spinal Fixation SystemGS120-1700GS120-17002026-08-18
08800322750834PYXIS 3D Titanium Cage SystemGS138-5814GS138-58142026-08-18
08800322758106PYXIS 3D Titanium Cage SystemGS138-5815GS138-58152026-08-18
08800322758113PYXIS 3D Titanium Cage SystemGS138-5816GS138-58162026-08-18
08800322759516Torque Limiting HandleGS112-0611GS112-06112026-08-18
08800322759523QUASAR Standalone ACIF SystemGS136-8205GS136-82052026-08-18
08800322759530QUASAR Standalone ACIF SystemGS136-8207GS136-82072026-08-18
08800322759547QUASAR Standalone ACIF SystemGS136-8209GS136-82092026-08-18
08800322759554QUASAR Standalone ACIF SystemGS136-8211GS136-82112026-08-18
08800322759561QUASAR Standalone ACIF SystemGS136-8405GS136-84052026-08-18
08800322759578QUASAR Standalone ACIF SystemGS136-8407GS136-84072026-08-18
08800322759585QUASAR Standalone ACIF SystemGS136-8409GS136-84092026-08-18
08800322759592QUASAR Standalone ACIF SystemGS136-8411GS136-84112026-08-18
08806395408481DistractorGS133-1157GS133-11572026-08-18
08809974805459PYXIS 3D Titanium Cage SystemGS132-1008PGS132-1008P2026-08-18
08809974805466PYXIS 3D Titanium Cage SystemGS132-1009PGS132-1009P2026-08-18
08809974805473PYXIS 3D Titanium Cage SystemGS132-1010PGS132-1010P2026-08-18
08809974805480PYXIS 3D Titanium Cage SystemGS132-1012PGS132-1012P2026-08-18
08809974805497PYXIS 3D Titanium Cage SystemGS132-1014PGS132-1014P2026-08-18
08809974805503PYXIS 3D Titanium Cage SystemGS132-1016PGS132-1016P2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776411541MillenniumAvalign Technologies, Inc.HWA2026-08-07
03701089527934AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089527941AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089527958AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089528450AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089547512AMPLITUDEAMPLITUDE SASHWA2026-07-29
18257200103188ALLOGRAFT - CORTICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHWA2026-07-17
18257200103881ALLOQUENT - ALIFOrthofix US LLCHWA2026-07-17
18257200103898ALLOQUENT - ALIFOrthofix US LLCHWA2026-07-17
00822409135721N/AOrtho Development CorporationHWA2026-07-16
07630055307781Positioning handle - M8x1 interfaceIncipio Devices SAHWA2026-07-16
07630055307798Positioning handle - M10x1.5 interfaceIncipio Devices SAHWA2026-07-16
07630055307804Offset Cup Impactor - M8x1 interfaceIncipio Devices SAHWA2026-07-16
07630055307811Offset Cup Impactor - M10x1.5 interfaceIncipio Devices SAHWA2026-07-16
00840286860406Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWA2026-07-09
00885556925690NASmith & Nephew, Inc.HWA2026-06-04
10603295543718ATTUNEDEPUY (IRELAND)HWA2025-10-31
10603295543725ATTUNEDEPUY (IRELAND)HWA2025-10-31
00841732162709GENERIC Surgical InstrumentsCTL Medical CorporationHWA2023-09-27
00841732162716GENERIC Surgical InstrumentsCTL Medical CorporationHWA2023-09-27
07613327538601INSTRUMENTHowmedica Osteonics Corp.HWA2023-06-30
10603295549581INHANCEDEPUY (IRELAND)HWA2023-02-28
10603295539346INHANCEDEPUY (IRELAND)HWA2021-08-30
07630055302458Offset Cup Impactor - M8x1 interfaceIncipio Devices SAHWA2020-04-23
07630055302465Offset Cup Impactor - M10x1.5 interfaceIncipio Devices SAHWA2020-04-23
07640178983052JULIET ® INSTRUMENTATIONSpineArt SAHWA2019-02-01
10705034717364NASynthes GmbHHWA2019-01-18
10603295423324ATTUNEDEPUY (IRELAND)HWA2018-09-24
M684201620111MICROPORTMicroport Orthopedics Inc.HWA2018-09-13
10705034720883NASYNTHES (U.S.A.) LPHWA2018-08-17