FDA.reportPublic FDA data

RIVA Posterior Fixation System

Primary DI
00840493413778
Brand
RIVA Posterior Fixation System
Company
XENIX MEDICAL LLC
Model
FG1-A5-000061
Catalog number
FG1-A5-000061
Device description
Extended Tab Breaker, Tube
Published
2025-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840493413778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493413778008404934137788404934137780840493413778

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantable-device cutterA heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080386764
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840493423166RIVA Pedicle Screw SystemFG1-16-202025FG1-16-2020252026-06-08
00840493423173RIVA Pedicle Screw SystemFG1-16-202030FG1-16-2020302026-06-08
00840493423180RIVA Pedicle Screw SystemFG1-16-202035FG1-16-2020352026-06-08
00840493423197RIVA Pedicle Screw SystemFG1-16-202040FG1-16-2020402026-06-08
00840493423203RIVA Pedicle Screw SystemFG1-16-202045FG1-16-2020452026-06-08
00840493423210RIVA Pedicle Screw SystemFG1-16-202050FG1-16-2020502026-06-08
00840493423227RIVA Pedicle Screw SystemFG1-16-202055FG1-16-2020552026-06-08
00840493423234RIVA Pedicle Screw SystemFG1-16-202060FG1-16-2020602026-06-08
00840493423241RIVA Pedicle Screw SystemFG1-16-202065FG1-16-2020652026-06-08
00840493423258RIVA Pedicle Screw SystemFG1-16-202070FG1-16-2020702026-06-08
00840493423265RIVA Pedicle Screw SystemFG1-16-202075FG1-16-2020752026-06-08
00840493423272RIVA Pedicle Screw SystemFG1-16-202080FG1-16-2020802026-06-08
00840493423289RIVA Pedicle Screw SystemFG1-16-202085FG1-16-2020852026-06-08
00840493423296RIVA Pedicle Screw SystemFG1-16-202090FG1-16-2020902026-06-08
00840493423302RIVA Pedicle Screw SystemFG1-16-202095FG1-16-2020952026-06-08
00840493423319RIVA Pedicle Screw SystemFG1-16-202100FG1-16-2021002026-06-08
00840493423326RIVA Pedicle Screw SystemFG1-16-202110FG1-16-2021102026-06-08
00840493423333RIVA Pedicle Screw SystemFG1-16-202120FG1-16-2021202026-06-08
00840493423340RIVA Pedicle Screw SystemFG1-16-202130FG1-16-2021302026-06-08
00840493423357RIVA Pedicle Screw SystemFG1-16-202140FG1-16-2021402026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449010196Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449010288Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035243Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035250Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035267Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035281Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035298Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035304Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035311Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035328Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035335Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035366Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035380Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035397Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035465Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035472Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00810094692698Modular Frog EyesTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692704Distal Femoral Cut Block ConnectorTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692933Magnet Spacer, 5mmTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
04052536123728mamboUlrich GmbH & Co. KGLXH2026-06-09
08809945870578BENCOXCorentec Co., LtdLXH2026-06-09
04052536085668neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162048neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162079neon3Ulrich GmbH & Co. KGLXH2026-06-08
00198506091445ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-05
00199150076161Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-05
00840311263882Streamline OCTXtant Medical Holdings, Inc.LXH2026-06-04
00198506091179ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-03
08698940967426SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03