FDA.reportPublic FDA data

PYXIS 3D Titanium Cage System

Primary DI
08800104098437
Brand
PYXIS 3D Titanium Cage System
Company
GS Medical Co., Ltd.
Model
GS167-1800
Catalog number
GS167-1800
Device description
3D TLIF Cage Inserter
Published
2024-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
08800104098437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800104098437088001040984378800104098437

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. 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
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
07613327697209PANGEAStryker GmbHLXH2026-08-27
00840606185950ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185967ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185974ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185981ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185998ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186001ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186018ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186025ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186032ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186049ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186056ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186063ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186070ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186087ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186094ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186100ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186117ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186124ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186131ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186148ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186155ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186162ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186179ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186186ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186193ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186209ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186247ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186254ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186414ALIFSPINAL ELEMENTS, INC.LXH2026-08-26